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Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoass…
EUDAMEDClass B (EU MDR)
Ref 05010301342Model 2 × 50 Tests; 2 × 100 Tests; 4 × 50 Tests; 4 × 100 Tests
Identity
- Device Name
- Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoassay, LiCA) EUDAMED
- Model / Reference
- 2 × 50 Tests; 2 × 100 Tests; 4 × 50 Tests; 4 × 100 Tests EUDAMED05010301342 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864380042 EUDAMED
- Basic UDI-DI
- 6978364380004FA EUDAMED
- Direct Marketing DI
- 06973864380042 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoass… by Chemclin Diagnostics Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6978364380004FA | Class B | Active |
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Manufacturer
- Manufacturer
- Chemclin Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000009729
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 585cdb15-1329-4178-930a-cc82868c5cc5 61 fields · synced Jun 19, 2026