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Follicle-Stimulating Hormone Test
EUDAMEDClass IVD General (EU MDR)
Ref FSH-U11 FSH-U23 FSH-U35Model FSH-U11, FSH-U23, FSH-U35
Identity
- Trade Name
- Follicle-Stimulating Hormone Test EUDAMED
- Device Name
- Follicle-Stimulating Hormone Test EUDAMED
- Model / Reference
- FSH-U11, FSH-U23, FSH-U35 EUDAMEDFSH-U11 FSH-U23 FSH-U35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804816773 EUDAMED
- Basic UDI-DI
- B-06952804816773 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Follicle-Stimulating Hormone Test by Assure Tech. (hangzhou) 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-06952804816773 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 98e8f6e5-0420-409f-acb6-d7cf96e6c9f6 61 fields · synced May 22, 2026