Registrant profile
Guangzhou Darui Biotechnology Co., Ltd.
广州市达瑞生物技术股份有限公司
Guangdong·China NMPA·260 registered devices
260
Total devices
2
Device classes
2017
Earliest approval
2024
Latest approval
Company overview
- Total devices
- 260
- Province/Region
- Guangdong广东
- Address
- No. 6 Lizhishan Road, Guangzhou High-tech Industrial Development Zone, No. 2 No. 404广州市高新技术产业开发区荔枝山路6号自编2号404
Registration timeline
- Earliest approval
- Mar 28, 2017
- Latest approval
- Nov 21, 2024
Device class distribution
Breakdown of 260 devices by regulatory classification
Class II
193
74.2% of total
Class III
67
25.8% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
| Product name | Class | Registration number | Approval date | Expiry date | Detail |
|---|---|---|---|---|---|
Immune suppressant quality control product 免疫抑制剂质控品 | Class II | 粤械注准20242401552 | Nov 21, 2024 | Nov 20, 2029 | View |
儿茶酚胺及代谢物质控品 | Class II | 粤械注准20242401536 | Nov 15, 2024 | Nov 14, 2029 | View |
儿茶酚胺及代谢物质控品 | Class II | 粤械注准20242401537 | Nov 15, 2024 | Nov 14, 2029 | View |
Steroid hormone controls 类固醇激素质控品 | Class II | 粤械注准20242401493 | Nov 06, 2024 | Nov 05, 2029 | View |
全谱维生素质控品 | Class II | 粤械注准20242401424 | Oct 25, 2024 | Oct 24, 2029 | View |
Human Elastase Inhibitor Protein (Elafin) Calibrator 人弹性蛋白酶抑制蛋白（Elafin）校准品 | Class II | 粤械注准20242401235 | Sep 13, 2024 | Sep 12, 2029 | View |
Time-of-flight mass spectrometry detection system 飞行时间质谱检测系统 | Class II | 粤械注准20242221066 | Aug 15, 2024 | Aug 14, 2029 | View |
丙型肝炎病毒抗体（HCV）对照品 | Class III | 国械注准20243401117 | Jun 18, 2024 | Jun 17, 2029 | View |
S100 Protein Assay Kit (Chemiluminescence Immunoassay) S100蛋白测定试剂盒（化学发光免疫分析法） | Class II | 粤械注准20232401667 | Oct 11, 2023 | Oct 10, 2028 | View |
Carbohydrate antigen 242 assay kit (chemiluminescence immunoassay) 糖类抗原242测定试剂盒（化学发光免疫分析法） | Class II | 粤械注准20232401549 | Sep 15, 2023 | Sep 14, 2028 | View |
About this profile
Complete regulatory portfolio for Guangzhou Darui Biotechnology Co., Ltd. in China's medical device market. This registrant has 260 medical devices registered with China NMPA, with registrations dating from Mar 28, 2017 to Nov 21, 2024.
Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.