News Updates
Guangdong Province Announces the Results of Quality Management System Inspections for Medical Device Registrations in April 2020.
Release date:
2020-12-18 17:13
Source:
China Quality News Network
China Quality News reports that on May 27, the Guangdong Provincial Drug Administration published on its official website the results of quality management system inspections for medical device registrations conducted in April 2020.
| Application Number | Company Name | Product Name | Verification Conclusion |
| 00A22000020200040 | Zhuhai Pusheng Medical Technology Co., Ltd. | Electronic endoscope image processor | Passed after rectification |
| 00A22000020200070 | Shenzhen Ailikon Medical Co., Ltd. | Medical electronic thermometer | Passed after rectification |
| 00A22000020200071 | Shenzhen Ailikon Medical Co., Ltd. | Infrared forehead thermometer | Passed after rectification |
| 00A22000020200072 | Shenzhen Ailikon Medical Co., Ltd. | Arm-type electronic sphygmomanometer | Passed after rectification |
| 00A22000020191377 | Shenzhen Silicon-Based Intelligent Technology Co., Ltd. | AI-based retinal image screening software for diabetic retinopathy | Passed after rectification |
| 00A22000020191519 | Shenzhen Chuanshi Biomedical Co., Ltd. | Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method) | Passed after rectification |
| 00A22000020191520 | Shenzhen Chuanshi Biomedical Co., Ltd. | Fibrinogen (FIB) Assay Kit (Clotting Method) | Passed after rectification |
| 00A22000020191521 | Shenzhen Chuanshi Biomedical Co., Ltd. | Prothrombin Time (PT) Assay Kit (Clotting Method) | Passed after rectification |
| 00A22000020191522 | Shenzhen Chuanshi Biomedical Co., Ltd. | Thrombin Time (TT) Assay Kit (Clotting Method) | Passed after rectification |
| 00A22000020200103 | Jiaside Technology (Shenzhen) Co., Ltd. | Oxygen concentration meter | Passed after rectification |
| 00A22000020200105 | Jiaside Technology (Shenzhen) Co., Ltd. | Disposable wireless electronic thermometer | Passed after rectification |
| 00A22000020200008 | Shenzhen Yeju Industrial Co., Ltd. | Single-use contrast catheter | Passed after rectification |
| 00A22000020200107 | Shenzhen Rongjie Xing Medical Equipment Co., Ltd. | Endoscope Cleaning and Disinfection Workstation | Passed after rectification |
| 00A22000020200044 | Guangzhou Panyu Huaxin Technology Co., Ltd. | Urine Sediment Analyzer | Passed after rectification |
| 00A22000020200283 | Heyuan Leyuan Intelligent Technology Co., Ltd. | Infrared thermometer | Passed after rectification |
| 00A22000020200315 | Hongxinlong Medical Technology (Qingyuan) Co., Ltd. | Infrared forehead thermometer | Passed after rectification |
| 00A22000020191440 | Shenzhen Jinrui Biotechnology Co., Ltd. | N-Terminal Pro‑Brain Natriuretic Peptide (NT‑proBNP) Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191441 | Shenzhen Jinrui Biotechnology Co., Ltd. | Small, Dense Low-Density Lipoprotein Cholesterol (sd LDL‑C) Assay Kit (Peroxidase Method) | Passed after rectification |
| 00A22000020191507 | Shenzhen Jinrui Biotechnology Co., Ltd. | High-sensitivity cardiac troponin I (hs‑cTnI) assay kit (chemiluminescent immunoassay) | Passed after rectification |
| 00A22000020200001 | Shenzhen Sanzhuan Medical Technology Co., Ltd. | Customized orthodontic appliance | Passed after rectification |
| 00A22000020200046 | Shenzhen Ante Medical Co., Ltd. | High-pressure syringe | Passed after rectification |
| 00A22000020200108 | Jiaside Technology (Shenzhen) Co., Ltd. | Wireless electronic thermometer | Passed after rectification |
| 00A22000020191430 | Shenzhen Jinrui Biotechnology Co., Ltd. | Interleukin-6 (IL-6) Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191442 | Shenzhen Jinrui Biotechnology Co., Ltd. | Anti-Thyroglobulin Antibody (TGA) Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191443 | Shenzhen Jinrui Biotechnology Co., Ltd. | Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191445 | Shenzhen Jinrui Biotechnology Co., Ltd. | Anti-Thyroid Peroxidase Antibody (Anti-TPO) Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200104 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | High-sensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunonephelometric turbidimetric method) | Exempted Site |
| 00A22000020200109 | Shenzhen Mecotian Biomedical Technology Co., Ltd. | D-Dimer Assay Kit (Chemiluminescent Immunoassay) | Exempted Site |
| 00A22000020200110 | Shenzhen Mecotian Biomedical Technology Co., Ltd. | D-Dimer Assay Kit (Chemiluminescent Immunoassay) | Exempted Site |
| 00A22000020200112 | Guangzhou Baishi Medical Technology Co., Ltd. | Radiation therapy contouring software | Passed after rectification |
| 00A22000020200073 | Aiorle Medical Devices (Shenzhen) Co., Ltd. | Blood Glucose/Uric Acid/Total Cholesterol Analyzer | Passed after rectification |
| 00A22000020200074 | Aiorle Medical Devices (Shenzhen) Co., Ltd. | Uric acid analyzer | Passed after rectification |
| 00A22000020200075 | Shenzhen Shentu Medical Imaging Equipment Co., Ltd. | Digital X-ray Imaging System | Passed after rectification |
| 00A22000020200069 | Shenzhen Shentu Medical Imaging Equipment Co., Ltd. | Digital Intraoral Imaging Plate Scanning and Processing System | Passed after rectification |
| 00A22000020191484 | Guangdong Fujiang Medical Technology Co., Ltd. | Single-use flexible endoscopic tissue forceps | Passed after rectification |
| 00A22000020191486 | Guangdong Fujiang Medical Technology Co., Ltd. | Single-use guidewire for the gastrointestinal and airway tracts | Passed after rectification |
| 00A22000020191487 | Guangdong Fujiang Medical Technology Co., Ltd. | Single-use endoscopic stone retrieval basket | Passed after rectification |
| 00A22000020200047 | Shenzhen Bestar Medical Co., Ltd. | Medical Diagnostic X-ray Imaging System | Passed after rectification |
| 00A22000020200113 | Guangzhou Wondfo Biotech Co., Ltd. | Fully Automated Nucleic Acid Detection and Analysis System | Passed after rectification |
| 00A22000020200236 | Guangzhou Youwo Medical Supplies Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200316 | Shenzhen Xingye Zhuohui Industrial Co., Ltd. | Medical Disposable Protective Clothing (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200260 | Shenzhen Furui Nuo Technology Co., Ltd. | Infrared thermometer | Passed after rectification |
| 00A22000020200274 | Shenzhen Baoshenxin Technology Electronics Co., Ltd. | Non-contact infrared thermometer | Passed after rectification |
| 00A22000020200296 | Huizhou Xiaoou Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200312 | Shenzhen Shenrui Medical Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200330 | Guangzhou Zhongqi Commercial Machinery Co., Ltd. | Infrared thermometer | Passed after rectification |
| 00A22000020200332 | Guangzhou Qiyankang Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200088 | Huizhou Huali Medical Co., Ltd. | Negative Pressure Dressing Kit | Passed after rectification |
| 00A22000020191471 | Guangdong Zhongrun Intelligent Manufacturing Medical Equipment Co., Ltd. | Multifunctional Microcomputer Therapeutic Device | Passed after rectification |
| 00A22000020191472 | Shenzhen Yuandong Innovation Technology Co., Ltd. | Pulse oximeter | Passed after rectification |
| 00A22000020191473 | Shenzhen Yuandong Innovation Technology Co., Ltd. | Holter monitor | Passed after rectification |
| 00A22000020191475 | Shenzhen Yuandong Innovation Technology Co., Ltd. | Electrocardiograph | Passed after rectification |
| 00A22000020200115 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Fully automatic biochemical analyzer | Passed after rectification |
| 00A22000020191459 | Dongguan Jianda Information Technology Co., Ltd. | Polysomnographic Sleep-Disordered Breathing Analysis Software System | Passed after rectification |
| 00A22000020200128 | Shenzhen Kaile Biomedical Technology Co., Ltd. | Color Doppler Ultrasound Diagnostic System | Passed after rectification |
| 00A22000020200129 | Shenzhen Kaile Biomedical Technology Co., Ltd. | Color Doppler Ultrasound Diagnostic System | Passed after rectification |
| 00A22000020200191 | Shenzhen Kaile Biomedical Technology Co., Ltd. | Medical Imaging Information Management Software | Passed after rectification |
| 00A22000020200135 | Guangdong Tianyou Medical Device Technology Development Co., Ltd. | Single-use endoscopic stone retrieval basket | Passed after rectification |
| 00A22000020200138 | Guangdong Tianyou Medical Device Technology Development Co., Ltd. | Single-use non-vascular lumen guidewire | Passed after rectification |
| 00A22000020200140 | Guangdong Tianyou Medical Device Technology Development Co., Ltd. | Single-use minimally invasive dilation and drainage kit | Passed after rectification |
| 00A22000020200141 | Guangdong Tianyou Medical Device Technology Development Co., Ltd. | Single-use ureteral access sheath | Passed after rectification |
| 00A22000020200142 | Guangdong Tianyou Medical Device Technology Development Co., Ltd. | Single-use sterile ureteral catheterization stent | Passed after rectification |
| 00A22000020200111 | Zhuhai Biso Biotechnology Co., Ltd. | Fully Automated Mycobacterium Culture Monitoring System | Passed after rectification |
| 00A22000020200100 | Zhuhai Biso Biotechnology Co., Ltd. | Non-tuberculous mycobacteria susceptibility test kit | Passed after rectification |
| 00A22000020200099 | Zhuhai Biso Biotechnology Co., Ltd. | Mycobacterial Liquid Susceptibility Test Reagent (Fluorescence Method) | Passed after rectification |
| 00A22000020200004 | Zhuhai Lingte Medical Instrument Co., Ltd. | Medical ultrasonic nebulizer | Passed after rectification |
| 00A22000020200431 | Guangdong Jinfa Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200438 | Guangdong Jinfa Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200334 | Single-use medical mask | Shenzhen Baishi Health Pharmaceutical Co., Ltd. | Passed after rectification |
| 00A22000020200183 | Steady Medical Products Co., Ltd. | Medical disposable protective suit | Passed after rectification |
| 00A22000020200124 | Zhuhai Livzon Reagent Co., Ltd. | ABO Forward Grouping and RhD Blood Group Test Reagent (Filtration Method) | Passed after rectification |
| 00A22000020200076 | Mido Medical Technology (Zhongshan) Co., Ltd. | Urine Microalbumin Assay Kit (Nephelometric Turbidimetric Method) | Passed after rectification |
| 00A22000020200077 | Mido Medical Technology (Zhongshan) Co., Ltd. | Retinol-Binding Protein Assay Kit (Latex‑Enhanced Nephelometric Method) | Passed after rectification |
| 00A22000020200078 | Mido Medical Technology (Zhongshan) Co., Ltd. | Transferrin Assay Kit (Latex‑Enhanced Nephelometric Method) | Passed after rectification |
| 00A22000020200079 | Mido Medical Technology (Zhongshan) Co., Ltd. | Total Urinary Protein Assay Kit (O‑Phenanthroline Red–Molybdenum Method) | Passed after rectification |
| 00A22000020200080 | Mido Medical Technology (Zhongshan) Co., Ltd. | α1-Microglobulin Assay Kit (Nephelometric Turbidimetric Method) | Passed after rectification |
| 00A22000020200081 | Mido Medical Technology (Zhongshan) Co., Ltd. | α2-Macroglobulin Assay Kit (Nephelometric Method) | Passed after rectification |
| 00A22000020200125 | Zhuhai Livzon Reagent Co., Ltd. | ABO Forward Grouping Blood Typing Reagent (Filtration Method) | Passed after rectification |
| 00A22000020200127 | Zhuhai Livzon Reagent Co., Ltd. | RhD Blood Group Test Reagent (Osmotic Lysis Method) | Passed after rectification |
| 00A22000020200167 | Zhuhai Livzon Reagent Co., Ltd. | Tuberculosis Infection T-Cell Assay Kit (Chemiluminescence Method) | Passed after rectification |
| 00A22000020200169 | Zhuhai Livzon Reagent Co., Ltd. | Interferon-gamma reference standard | Passed after rectification |
| 00A22000020200061 | Mido Medical Technology (Zhongshan) Co., Ltd. | N-Acetyl-β-D-glucosaminidase Assay Kit (MPT Substrate Method) | Passed after rectification |
| 00A22000020200062 | Mido Medical Technology (Zhongshan) Co., Ltd. | Neutrophil Gelatinase-Associated Lipid Transporter Assay Kit (Latex‑Enhanced Nephelometric Method) | Passed after rectification |
| 00A22000020200063 | Mido Medical Technology (Zhongshan) Co., Ltd. | β2-Microglobulin Assay Kit (Latex‑Enhanced Nephelometric Method) | Passed after rectification |
| 00A22000020200064 | Mido Medical Technology (Zhongshan) Co., Ltd. | Creatinine Assay Kit (Sarcosine Oxidase Method) | Passed after rectification |
| 00A22000020200065 | Mido Medical Technology (Zhongshan) Co., Ltd. | Urine Iodine Assay Kit (Arsenic-Cerium Catalytic Method) | Passed after rectification |
| 00A22000020200477 | Dongguan Furundede Precision Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200066 | Mido Medical Technology (Zhongshan) Co., Ltd. | Immunoglobulin G Assay Kit (Nephelometric Method) | Passed after rectification |
| 00A22000020200067 | Mido Medical Technology (Zhongshan) Co., Ltd. | κ Light Chain Assay Kit (Nephelometric Turbidimetric Method) | Passed after rectification |
| 00A22000020200068 | Mido Medical Technology (Zhongshan) Co., Ltd. | Lambda Light Chain Assay Kit (Nephelometric Method) | Passed after rectification |
| 00A22000020200238 | Guangdong Ziwai Xing Health Industry Co., Ltd. | Ultra-long-wavelength electromagnetic therapy device | Passed after rectification |
| 00A22000020200139 | Zhuhai Meihao Technology Co., Ltd. | Holter monitor | Passed after rectification |
| 00A22000020200176 | Zhuhai Livzon Reagent Co., Ltd. | Colloidal Gold Test Strip Analyzer | Passed after rectification |
| 00A22000020200177 | Zhuhai Livzon Reagent Co., Ltd. | Anti-Müllerian Hormone Assay Kit (Chemiluminescent Method) | Passed after rectification |
| 00A22000020200178 | Zhuhai Livzon Reagent Co., Ltd. | Anti-Müllerian Hormone Calibrator | Passed after rectification |
| 00A22000020191448 | Zhongshan Pulisi Minimally Invasive Interventional Medical Device Co., Ltd. | Single-use epidural anesthesia catheter | Passed after rectification |
| 00A22000020200154 | Zhuhai Dafushui Medical Technology Co., Ltd. | Single-use nebulizer mask | Passed after rectification |
| 00A22000020200155 | Zhuhai Dafushui Medical Technology Co., Ltd. | Single-use cervical forceps | Passed after rectification |
| 00A22000020200160 | Foshan Anlun Medical Device Co., Ltd. | 24-hour corrosion-resistant precision urine meter | Passed after rectification |
| 00A22000020200161 | Foshan Anlun Medical Device Co., Ltd. | Urine Sediment Analyzer (with Preservative) | Passed after rectification |
| 00A22000020191122 | Foshan Anchi Biotechnology Co., Ltd. | Dental implant | Passed after rectification |
| 00A22000020191123 | Foshan Anchi Biotechnology Co., Ltd. | Abutment system | Passed after rectification |
| 00A22000020191135 | Guangzhou Peimai Medical Technology Co., Ltd. | Intracranial external drainage catheter | Passed after rectification |
| 00A22000020191489 | Guangzhou Chuangyou Materials Technology Co., Ltd. | Orthodontic bracket | Passed after rectification |
| 00A22000020200264 | Shenzhen Zhongyue Health Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200012 | Guangzhou Hetai Biotechnology Co., Ltd. | Single-use self‑collecting cervical sampling brush | Passed after rectification |
| 00A22000020200350 | Shenzhen Qikang Medical Device Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200352 | Shenzhen Qikang Medical Device Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200369 | Huizhou Jixun Electronics Co., Ltd. | Medical infrared thermometer | Passed after rectification |
| 00A22000020200134 | Shenzhen Guardian Technology Co., Ltd. | Cervicothoracic and Lumbar Spine Three-Dimensional Curvature Traction Device | Passed after rectification |
| 00A22000020200245 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Portable Color Doppler Ultrasound System | Exempted Site |
| 00A22000020200190 | Shenzhen Chuanshi Biomedical Co., Ltd. | D-Dimer Assay Kit (Immunoturbidimetric Method) | Passed after rectification |
| 00A22000020200250 | Shenzhen Lepu Intelligent Medical Device Co., Ltd. | Medical oxygen concentrator | Passed after rectification |
| 00A22000020200136 | Guangzhou Hexinkangyuan Medical Technology Co., Ltd. | Fully Automated Microbial Mass Spectrometry Detection System | Passed after rectification |
| 00A22000020200179 | Guangzhou RanShi Medical Laboratory Co., Ltd. | Tumor Gene Mutation Sequencing Data Analysis Software | Passed after rectification |
| 00A22000020200355 | Shenzhen Fuxin Industrial Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200356 | Shenzhen Fuxin Industrial Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200358 | Guangdong Jiaqi Science and Education Co., Ltd. | Medical Non-Contact Infrared Forehead Thermometer | Passed after rectification |
| 00A22000020200322 | Shenzhen Bo Yingte Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200370 | Shenzhen Fangzhengyang Intelligent Electrical Appliances Co., Ltd. | Non-contact infrared forehead thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200351 | Zhongshan Tianmu Precision Control Intelligent Technology Co., Ltd. | Non-contact infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200143 | Shenzhen Shengyun Long Dental Prosthetics Co., Ltd. | Customized fixed dental prostheses | Passed after rectification |
| 00A22000020200413 | Hongsun Medical Supplies Co., Ltd. of Heping County | Single-use medical mask (emergency pandemic product, non-sterile) | Passed after rectification |
| 00A22000020200437 | Guangzhou Fengle Medical Technology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200480 | Guangzhou Fengle Medical Technology Co., Ltd. | Medical surgical mask (emergency pandemic product, non-sterile) | Passed after rectification |
| 00A22000020200144 | Shenzhen Shengyun Long Dental Prosthetics Co., Ltd. | Customized removable denture | Passed after rectification |
| 00A22000020200145 | Shenzhen Dejia Medical Device Co., Ltd. | Engine-driven root canal files | Passed after rectification |
| 00A22000020200365 | Zhongshan Wilton Electronic Technology Co., Ltd. | Non-contact thermometer | Failed |
| 00A22000020200164 | Shenzhen Zhengsheng Technology Co., Ltd. | Medical infrared thermometer | Passed after rectification |
| 00A22000020200166 | Shenzhen Lepu Intelligent Medical Device Co., Ltd. | Finger-clip pulse oximeter | Passed after rectification |
| 00A22000020200202 | Guangzhou Sanrui Medical Device Co., Ltd. | Labor monitoring system | Passed after rectification |
| 00A22000020200430 | UNI-T Technologies (China) Co., Ltd. | Non-contact infrared forehead thermometer | Passed after rectification |
| 00A22000020200432 | UNI-T Technologies (China) Co., Ltd. | Non-contact infrared forehead thermometer | Passed after rectification |
| 00A22000020200366 | Shenzhen Peninsula Medical Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200317 | Shenzhen Chuangmayou Precision Electronics Co., Ltd. | Non-contact infrared sensor | Passed after rectification |
| 00A22000020191460 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Hepatitis B Virus Core Antibody Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200367 | Shenzhen Jinyune Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020191439 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Hepatitis B Virus e-Antigen Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191482 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Gastrin-Releasing Peptide Precursor Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200153 | Shenzhen Ruikang Hongye Technology Development Co., Ltd. | Holter monitoring system | Passed after rectification |
| 00A22000020200082 | Guangdong Unide Biotechnology Co., Ltd. | Antinuclear Antibody Profile Test Kit (Immunoblotting Method) | Passed after rectification |
| 00A22000020200472 | Guangdong Shitaibao Medical Technology Co., Ltd. | Medical infrared thermometer | Passed after rectification |
| 00A22000020200348 | Shenzhen Shige Innovative Medical Technology Co., Ltd. | Medical Disposable Protective Clothing (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020190895 | Shenzhen Puruida Membrane Switch Technology Co., Ltd. | Single-use non-invasive EEG sensor | Failed |
| 00A22000020200499 | Guangdong Taibao Medical Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200360 | Shenzhen Jinhuo Lisheng Pharmaceutical Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200401 | Donghua Zhigaoyun Communication Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200402 | Donghua Zhigaoyun Communication Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200378 | Shenzhen Lijiang Health Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020191033 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020191034 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020191035 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020191036 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020191037 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020191049 | Shenzhen Hailin Medical Biotechnology Co., Ltd. | Portable B-mode ultrasound diagnostic device | Passed after rectification |
| 00A22000020200247 | Shenzhen Yingsitai Inspection and Testing Co., Ltd. | Single-use medical mask (emergency pandemic product) | Failed |
| 00A22000020200406 | Shenzhen Haoyuan Electronics Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200426 | Guangzhou Chaoliang Electronic Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200385 | Guangdong Litai Pharmaceutical Co., Ltd. | Single-use medical mask (non-sterile) | Passed after rectification |
| 00A22000020200554 | BYD Precision Manufacturing Co., Ltd. | Medical protective mask | Exempted Site |
| 00A22000020200386 | Shenzhen Baisiman Precision Instruments Co., Ltd. | Medical infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200387 | Shenzhen Huayuan Youpu Medical Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200388 | Shenzhen Huayuan Youpu Medical Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200373 | Shenzhen Shangrong Medical Co., Ltd. | Single-use medical protective suit (emergency pandemic product) | Failed |
| 00A22000020200374 | Shenzhen Shangrong Medical Co., Ltd. | Single-use medical mask (emergency pandemic product) | Failed |
| 00A22000020200450 | Shenzhen Fubang New Technology Co., Ltd. | Non-contact infrared forehead thermometer | Passed after rectification |
| 00A22000020191418 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Herpes Simplex Virus Type 1 IgG Antibody Detection Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020191447 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Hepatitis B Virus e-Antibody Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200083 | Guangdong Unide Biotechnology Co., Ltd. | Glycated Hemoglobin Assay Kit (Immunoturbidimetric Method) | Passed after rectification |
| 00A22000020200186 | Shenzhen Kangli Biomedical Co., Ltd. | Calibration reagent for blood gas and electrolyte analyzer | Passed after rectification |
| 00A22000020200187 | Guangzhou Henghao Technology Co., Ltd. | Customized orthodontic appliance | Passed after rectification |
| 00A22000020200188 | Shenzhen Kangli Biomedical Co., Ltd. | Calibration reagent for blood gas and electrolyte analyzer | Passed after rectification |
| 00A22000020200156 | United Minimally Invasive Medical Devices (Shenzhen) Co., Ltd. | Single-use endoscopic surgical retrieval bag with sealed sheath | Passed after rectification |
| 00A22000020200157 | United Minimally Invasive Medical Devices (Shenzhen) Co., Ltd. | Single-use trocar | Passed after rectification |
| 00A22000020200240 | Shenzhen Pubo Technology Co., Ltd. | Handheld Wireless Color Doppler Ultrasound Diagnostic System | Passed after rectification |
| 00A22000020200206 | Shenzhen Jiamei Biotechnology Co., Ltd. | D-Dimer Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200207 | Shenzhen Jiamei Biotechnology Co., Ltd. | Cardiac Fatty Acid-Binding Protein (H-FABP) Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200208 | Shenzhen Jiamei Biotechnology Co., Ltd. | Myoglobin Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200209 | Shenzhen Jiamei Biotechnology Co., Ltd. | Myeloperoxidase (MPO) Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200210 | Shenzhen Jiamei Biotechnology Co., Ltd. | Creatine Kinase-MB/Myoglobin (CK‑MB/MYO) Combined Assay Kit (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200211 | Shenzhen Jiamei Biotechnology Co., Ltd. | Creatine Kinase-MB Isoenzyme (CK‑MB) Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200212 | Shenzhen Jiamei Biotechnology Co., Ltd. | Procalcitonin (PCT) Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200213 | Shenzhen Jiamei Biotechnology Co., Ltd. | N-terminal pro–brain natriuretic peptide (NT‑proBNP) assay kit (immunochromatographic assay) | Passed after rectification |
| 00A22000020200214 | Shenzhen Jiamei Biotechnology Co., Ltd. | High-throughput immunoassay analyzer | Passed after rectification |
| 00A22000020200215 | Shenzhen Jiamei Biotechnology Co., Ltd. | Multifunctional Fully Quantitative Immunoassay Analyzer | Passed after rectification |
| 00A22000020200218 | Shenzhen Jiamei Biotechnology Co., Ltd. | Cardiac Troponin I (cTnI) Test Reagent (Immunochromatographic Assay) | Passed after rectification |
| 00A22000020200221 | Shenzhen Ruijian Yixin Technology Co., Ltd. | Intelligent Management System for the Hemodialysis Center | Passed after rectification |
| 00A22000020200411 | Shenzhen Yingkai Biotechnology Co., Ltd. | Fully automatic chemiluminescence immunoassay analyzer | Exempted Site |
| 00A22000020200362 | Guangdong Haoyisheng Medical Technology Co., Ltd. | Medical infrared forehead thermometer | Passed after rectification |
| 00A22000020200555 | BYD Precision Manufacturing Co., Ltd. | Medical surgical mask | Exempted Site |
| 00A22000020200377 | Shenzhen Hongrui Sheng Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200435 | Shenzhen Baimingsheng Medical Device Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200444 | Jiangmen Erd Kangming Medical Device Co., Ltd. | Medical infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200364 | Guangzhou Demai Medical Device Co., Ltd. | Medical infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200276 | Guangdong TidaKang Medical Technology Co., Ltd. | Hydrocolloid dressing | Exempted Site |
| 00A22000020200513 | Guangzhou Weili Medical Device Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200196 | Shenzhen Oubailai Technology Co., Ltd. | Medical infrared forehead thermometer | Passed after rectification |
| 00A22000020200407 | Guangdong Baolite Medical Technology Co., Ltd. | Infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200460 | Shenzhen Yahuilong Biotechnology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200461 | Shenzhen Yahuilong Biotechnology Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200462 | Shenzhen Yahuilong Biotechnology Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200476 | Shenzhen Yahuilong Biotechnology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200515 | Shenzhen Dongdixin Technology Co., Ltd. | Non-contact infrared thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200466 | Zhongshan Shujiang Technology Co., Ltd. | Non-contact infrared thermometer | Passed after rectification |
| 00A22000020200504 | Guangzhou Kangbang Medical Equipment Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200540 | Dongguan Fuzekang Medical Device Technology Co., Ltd. | Forehead thermometer | Passed after rectification |
| 00A22000020200353 | Guangzhou Darui Reproductive Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200497 | Chuangqi Technology (Guangzhou) Co., Ltd. | Medical Infrared Forehead Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200582 | Zhongshun Jierou (Yunfu) Paper Industry Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200436 | Huizhou Lanwei Electronics Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200440 | Guangzhou ChenGeng Pharmaceutical Technology Development Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200131 | Guangdong Shunde Lingqingxiang Health Technology Co., Ltd. | Manual wheelchair | Passed after rectification |
| 00A22000020200171 | Foshan Shunde Jianhe Electronics Co., Ltd. | Medical molecular sieve oxygen concentrator | Passed after rectification |
| 00A22000020200514 | Guangzhou Kangyijian Medical Equipment Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200518 | Guangdong Weishan Technology Co., Ltd. | Non-contact infrared forehead thermometer (emergency pandemic product) | Passed after rectification |
| 00A22000020200506 | Guangzhou Kangling Medical Supplies Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200539 | Guangzhou Kangling Medical Supplies Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200463 | Topu Aozhida (Guangzhou) Medical Supplies Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200464 | Topu Aozhida (Guangzhou) Medical Supplies Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200469 | Dongguan Jinwenhua Digital Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200535 | Guangdong Xianlai Medical Device Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200543 | Rongjia (Huizhou) Medical Device Manufacturing Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200479 | Guangzhou Deshan CNC Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200415 | Guangdong Shilian Medical Device Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200428 | Shenzhen Meiyajie Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200446 | Guangdong Zhongxinke Medical Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200722 | Guangzhou Weili Medical Device Co., Ltd. | Medical surgical mask (emergency pandemic product) | Exempted Site |
| 00A22000020200244 | Guangzhou HuiBo Information Technology Co., Ltd. | Pelvic floor muscle therapy head | Passed after rectification |
| 00A22000020200488 | Guangzhou Qingding Commercial Operation and Management Co., Ltd. | Disposable medical mask (non-sterile) (emergency pandemic product) | Passed after rectification |
| 00A22000020200354 | Guangzhou Haoneng Electronic Technology Co., Ltd. | Medical infrared thermometer | Passed after rectification |
| 00A22000020200220 | Sino-Health Technology (Shenzhen) Co., Ltd. | Aortic covered stent balloon catheter | Passed after rectification |
| 00A22000020200490 | Shenzhen Jingke Industrial Co., Ltd. | Single-use medical mask (emergency pandemic product, non-sterile) | Passed after rectification |
| 00A22000020200475 | Shenzhen Shenshitai Electronic Technology Co., Ltd. | Infrared Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200417 | Shenzhen Fulusi Technology Co., Ltd. | Non-contact infrared thermometer (emergency pandemic product) | Failed |
| 00A22000020200182 | Zhongshan Chuangyi Biochemical Engineering Co., Ltd. | Quality control materials for hematology analyzers | Passed after rectification |
| 00A22000020200184 | Zhongshan Chuangyi Biochemical Engineering Co., Ltd. | Calibrator for hematology analyzers | Passed after rectification |
| 00A22000020200457 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Portable Color Doppler Ultrasound System | Exempted Site |
| 00A22000020200458 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Portable Color Doppler Ultrasound System | Exempted Site |
| 00A22000020191452 | Shenzhen Anqun Bioengineering Co., Ltd. | Thymidine Kinase 1 (TK1) Assay Kit (Chemiluminescent Method) | Passed after rectification |
| 00A22000020200086 | Shenzhen Guosai Biotechnology Co., Ltd. | Direct Bilirubin Assay Kit (Vanadate Oxidation Method) | Passed after rectification |
| 00A22000020200223 | Sino-Health Technology (Shenzhen) Co., Ltd. | Adjustable Curved Conveyor System | Passed after rectification |
| 00A22000020200230 | Sino-Health Technology (Shenzhen) Co., Ltd. | Peripheral balloon dilation catheter | Passed after rectification |
| 00A22000020200165 | Shenzhen Yeju Industrial Co., Ltd. | Spin-Formed Y-Type Connector Valve Kit | Passed after rectification |
| 00A22000020200163 | Shenzhen Yeju Industrial Co., Ltd. | Catheter sheath | Passed after rectification |
| 00A22000020200162 | Shenzhen Yeju Industrial Co., Ltd. | Catheter sheath | Passed after rectification |
| 00A22000020200219 | Sino-Health Technology (Shenzhen) Co., Ltd. | Iliac Artery Bifurcation Stent System | Passed after rectification |
| 00A22000020200241 | Shenzhen Bosheng Medical Device Co., Ltd. | Dynamic ECG and Blood Pressure Workstation | Passed after rectification |
| 00A22000020200242 | Shenzhen Bosheng Medical Device Co., Ltd. | Electrocardiograph Workstation | Passed after rectification |
| 00A22000020200087 | Shenzhen Guosai Biotechnology Co., Ltd. | Total Bilirubin Assay Kit (Vanadate Oxidation Method) | Passed after rectification |
| 00A22000020200094 | Shenzhen Guosai Biotechnology Co., Ltd. | D-Dimer Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200097 | Shenzhen Guosai Biotechnology Co., Ltd. | D-dimer quality control material | Passed after rectification |
| 00A22000020200098 | Shenzhen Guosai Biotechnology Co., Ltd. | N-terminal pro–brain natriuretic peptide (NT‑proBNP) assay kit (time-resolved fluorescence immunoassay) | Passed after rectification |
| 00A22000020200602 | Foshan Special Medical Catheter Co., Ltd. | Medical surgical mask | Passed after rectification |
| 00A22000020200521 | Shenzhen Zhongnuo Intelligent Technology Co., Ltd. | Medical Infrared Forehead Thermometer (Emergency Pandemic Product) | Passed after rectification |
| 00A22000020200638 | Guangdong Gefilin Medical Materials Technology Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200589 | Guangzhou BioGene Biotechnology Co., Ltd. | Medical protective clothing (emergency pandemic product) | Passed after rectification |
| 00A22000020200410 | Guangzhou Sanrong Hygiene Products Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200536 | Guangzhou Yueqing Regenerative Medicine Technology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200592 | Guangdong Zhengzhi Medical Technology Co., Ltd. | Single-use medical mask (sterile) | Passed after rectification |
| 00A22000020191116 | Shenzhen Mailuikelin Technology Co., Ltd. | Single-use sampling swab | Failed |
| 00A22000020191117 | Shenzhen Mailuikelin Technology Co., Ltd. | Single-use sampling swab | Failed |
| 00A22000020191118 | Shenzhen Mailuikelin Technology Co., Ltd. | Single-use sampling swab | Failed |
| 00A22000020191115 | Shenzhen Mailuikelin Technology Co., Ltd. | Single-use sampling swab | Failed |
| 00A22000020200199 | Shenzhen Anke High-Tech Co., Ltd. | X-ray computed tomography system | Passed after rectification |
| 00A22000020200251 | Shenzhen Tailode Medical Co., Ltd. | POCT biochemical analyzer | Passed after rectification |
| 00A22000020200246 | Shenzhen Anbao Technology Co., Ltd. | Cardiopulmonary resuscitation machine | Passed after rectification |
| 00A22000020200252 | Shenzhen Doudian Medical Technology Co., Ltd. | Disposable flocked sampling swab | Passed after rectification |
| 00A22000020200671 | Heyuan Zhongguang Optoelectronic Communication Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200820 | Zhongshun Jierou (Yunfu) Paper Industry Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200590 | Zhuhai Kanglilai Technology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200517 | Shenzhen Rongyu Medical Services Co., Ltd. | Single-use medical mask (emergency pandemic product, non-sterile) | Passed after rectification |
| 00A22000020200465 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Thyroid-Stimulating Hormone Receptor Antibody Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200470 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Anti-myeloperoxidase Antibody IgG Assay Kit (Chemiluminescent Immunoassay) | Passed after rectification |
| 00A22000020200297 | Shenzhen Tailode Medical Co., Ltd. | Aldosterone (ALD) Assay Kit (Magnetic Particle Chemiluminescence Method) | Passed after rectification |
| 00A22000020200298 | Shenzhen Tailode Medical Co., Ltd. | Myeloperoxidase (MPO) Assay Kit (Chemiluminescent Immunoassay on Magnetic Particles) | Passed after rectification |
| 00A22000020200299 | Shenzhen Tailode Medical Co., Ltd. | Renin Assay Kit (Magnetic Particle Chemiluminescence Method) | Passed after rectification |
| 00A22000020200616 | Beile (Guangzhou) Intelligent Information Technology Co., Ltd. | Infrared thermometer | Passed after rectification |
| 00A22000020200624 | Beile (Guangzhou) Intelligent Information Technology Co., Ltd. | Infrared thermometer | Passed after rectification |
| 00A22000020200583 | Foshan Nanhai Chuanzhishang Apparel Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200584 | Foshan Nanhai Chuanzhishang Apparel Co., Ltd. | Medical surgical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200418 | Guangdong Hongzhi Biotechnology Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200563 | Guangdong Shiwai Medical Technology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200492 | Shenzhen Jingwei Technology Co., Ltd. | Medical Infrared Forehead Thermometer (Emergency Pandemic Product) | Failed |
| 00A22000020200600 | Guangzhou Nuohua Electronic Technology Co., Ltd. | Infrared forehead thermometer | Failed |
| 00A22000020200605 | Guangdong Kewei Biotechnology Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200618 | Guangdong Jiutian Lv Pharmaceutical Co., Ltd. | Single-use medical mask | Passed after rectification |
| 00A22000020200703 | Dongguan Yichun Group Co., Ltd. | Single-use medical mask (emergency pandemic product) | Passed after rectification |
| 00A22000020200670 | Guangdong Keying Technology Co., Ltd. | Single-use medical mask (non-sterile, emergency pandemic product) | Passed after rectification |
| 00A22000020200268 | Shenzhen Jinghong Medical Technology Co., Ltd. | Electronic sphygmomanometer | Exempted Site |