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Follicle-Stimulating Hormone (FSH) Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref G2402CVRef G2403CVRef G2404CC
Identity
- Trade Name
- Follicle-Stimulating Hormone (FSH) Test Kit EUDAMED
- Device Name
- Follicle-Stimulating Hormone (FSH) Test Kit EUDAMED
- Model / Reference
- G2402CV EUDAMEDG2403CV EUDAMEDG2404CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739153 EUDAMED06979469761453 EUDAMED06979469761477 EUDAMED
- Basic UDI-DI
- B-06973315739153 EUDAMEDB-06979469761453 EUDAMEDB-06979469761477 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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 (FSH) Test Kit by Nanjing Vazyme Medical Technology 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-06973315739153 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED d0d0f1bb-2c10-4610-8461-ff8386beefe5 61 fields · synced Oct 6, 2026
- EUDAMED 4ca7bd23-a6da-4fc4-b269-3bd632255123 61 fields · synced Jun 20, 2026
- EUDAMED d83090fc-ba59-489b-aa43-19300d3527e8 61 fields · synced Jul 18, 2026