Follicle Stimulating Hormone (FSH) Test
by Nantong EgensBiotechnology Co., Ltd.
Ref FSH strip cassette midstreamModel strip cassette midstream
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-693757990301PQ D-693757990301PQ | Date11 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- strip cassette midstream, FSH strip cassette midstream
- Primary DI / UDI-DI
- D-693757990301PQ
- Basic UDI-DI
- B-693757990301PQ
- EMDN Code
- W0102050104 Follicle stimulating hormone
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000021561
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Nantong EgensBiotechnology Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No