Identity
- Trade Name
- FSH Rapid Quantitative Test EUDAMED
- Device Name
- FSH Rapid Quantitative Test (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- BT2205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260208432 EUDAMED
- Basic UDI-DI
- B-06933260208432 EUDAMED
- EMDN Code
- W0102160301 FSH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
FSH Rapid Quantitative Test by Xiamen Biotime Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06933260208432 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED fa248499-a1e5-4016-a125-cb684d3d4a69 61 fields · synced Oct 7, 2026