Ds-Eia-Gonadotropin-Fsh
by RPC Diagnostic Systems Ltd. Russia EUDAMED
Ref RH-151/1.1 EMDN W0102050104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04605979401566 | Date1 Oct 2025 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Withdrawn
Specification
- Device Name
- “ds-Eia-Gonadotropin-Fsh” Enzyme Immunoassay for the Quantitative Determination of Follicle Stimulating Hormone Concentration
- Model / Reference
- RH-151/1.1
- Primary DI / UDI-DI
- 04605979401566
- Basic UDI-DI
- B-04605979401566
- EMDN Code
- W0102050104 Follicle stimulating hormone
- Device Class
- Class IVD General
Manufacturer details
- EUDAMED SRN
- RU-MF-000043555
- Authorised representative
- AB Diagnostic Systems GmbH DE-AR-000025750
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 8722f8b0-021a-424c-9e32-474f969ad3b7