← Back to catalogue
Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref FSH-1011/FSH-1012/FSH-1013
Identity
- Trade Name
- Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) EUDAMED
- Device Name
- Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) EUDAMED
- Model / Reference
- FSH-1011/FSH-1012/FSH-1013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646MDOAS000825M EUDAMED
- Basic UDI-DI
- B-697424646MDOAS000825M EUDAMED
- EMDN Code
- W0102160301 FSH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Follicle-Stimulating Hormone (FSH) Rapid Test (Urine) by Safecare Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-697424646MDOAS000825M | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 04e8c558-ef78-40fb-a3e8-c9d85a7a116e 61 fields · synced Oct 6, 2026