Human Chorionic Gonadotropin Rapid Test (10mIU)
by Assure Tech. (Hangzhou) Co., Ltd. FDA registration: China EUDAMED
Ref A00010125Model Device, Strip, Midstream EMDN W0102160302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69528048A006100WQ | Date28 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 2279233CE01 Supplemented
Quality management system EU IVDR
- Notified body
- Notified body 0344
- Issued
- 10 Sep 2024
- Expires
- 1 Sep 2029
- Reason
- Add device or group
Specification
- Device Name
- Human Chorionic Gonadotropin Rapid Test (10mIU)
- Model / Reference
- Device, Strip, Midstream, A00010125
- Primary DI / UDI-DI
- 06952804838416
- Basic UDI-DI
- 69528048A006100WQ
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002170
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Assure Tech. (Hangzhou) Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06952804838416|69528048A006100WQ