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Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2019E-50Ref S2019E-100Ref S2019E-200
Identity
- Device Name
- Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2019E-50 EUDAMEDS2019E-100 EUDAMEDS2019E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737372 EUDAMED06955792737396 EUDAMED06955792737419 EUDAMED
- Basic UDI-DI
- B-06955792737372 EUDAMEDB-06955792737396 EUDAMEDB-06955792737419 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792737372 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 2b4609e4-1df4-4127-a0f0-173eb339427d 61 fields · synced Jul 9, 2026
- EUDAMED 03cad25d-ac31-4099-b3cf-5c6c184c6606 61 fields · synced May 17, 2026
- EUDAMED 46e3be53-9509-4709-a779-5476994784ef 61 fields · synced May 19, 2026