Human Chorionic Gonadotropin Combo Rapid Test (10/10mIU)
by Assure Tech. (Hangzhou) Co., Ltd.
Ref A00610125Model Device, Strip, Midstream
Active
CE IVDR
Valid until
1 Sep 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69528048A028100XU 06952804838591 | Date28 Aug 2026 | StatusActive |
Certificates
- 2279233CE01 Active
Quality management system EU IVDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 10 Sep 2024
- Expires
- 1 Sep 2029
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Human Chorionic Gonadotropin Combo Rapid Test (10/10mIU)
- Model / Reference
- Device, Strip, Midstream, A00610125
- Primary DI / UDI-DI
- 06952804838591
- Basic UDI-DI
- 69528048A028100XU
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- EU 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
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