Registrant profile
Autobio Diagnostics Co., Ltd.
郑州安图生物工程股份有限公司
Henan·China NMPA·550 registered devices
550
Total devices
2
Device classes
2015
Earliest approval
2025
Latest approval
Company overview
- Total devices
- 550
- Province/Region
- Henan河南
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone郑州经济技术开发区经北一路87号
Registration timeline
- Earliest approval
- May 19, 2015
- Latest approval
- Jan 20, 2025
Device class distribution
Breakdown of 550 devices by regulatory classification
Class II
383
69.6% of total
Class III
167
30.4% 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 |
|---|---|---|---|---|---|
铜绿假单胞菌/流感嗜血杆菌/大肠埃希菌核酸检测试剂盒（PCR-荧光探针法） | Class III | 国械注准20253400200 | Jan 20, 2025 | Jan 19, 2030 | View |
Thyroglobulin Antibody Calibration Kit 甲状腺球蛋白抗体校准品 | Class II | 豫械注准20252400053 | Jan 15, 2025 | Jan 14, 2030 | View |
甲状腺素校准品 | Class II | 豫械注准20252400052 | Jan 14, 2025 | Jan 13, 2030 | View |
三碘甲状腺原氨酸校准品 | Class II | 豫械注准20252400051 | Jan 14, 2025 | Jan 13, 2030 | View |
人表皮生长因子受体2校准品 | Class III | 国械注准20253400059 | Jan 10, 2025 | Jan 09, 2030 | View |
Cortisol calibration solution 皮质醇校准品 | Class II | 豫械注准20252400025 | Jan 10, 2025 | Jan 09, 2030 | View |
质谱分析校准品（N） | Class II | 豫械注准20252400027 | Jan 10, 2025 | Jan 09, 2030 | View |
Thyroid Peroxidase Antibody Calibration Material 甲状腺过氧化物酶抗体校准品 | Class II | 豫械注准20252400026 | Jan 10, 2025 | Jan 09, 2030 | View |
Free Thyroxine Calibration Product 游离甲状腺素校准品 | Class II | 豫械注准20252400023 | Jan 10, 2025 | Jan 09, 2030 | View |
Osteocalcin calibration kit 骨钙素校准品 | Class II | 豫械注准20252400024 | Jan 10, 2025 | Jan 09, 2030 | View |
About this profile
Complete regulatory portfolio for Autobio Diagnostics Co., Ltd. in China's medical device market. This registrant has 550 medical devices registered with China NMPA, with registrations dating from May 19, 2015 to Jan 20, 2025.
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.