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FSH Chemiluminescent Immunoassay Kit
EUDAMEDClass B (EU MDR)
Ref IM4402204 Model IM4402204 IM4403204 IM4406204 IM4407204
Identity
- Device Name
- FSH Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- IM4402204 IM4403204 IM4406204 IM4407204 EUDAMEDIM4402204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617401438 EUDAMED
- Basic UDI-DI
- 69506174IM440204D6 EUDAMED
- Direct Marketing DI
- 06950617401438 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
FSH Chemiluminescent Immunoassay Kit by Maccura Biotechnology Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69506174IM440204D6 | Class B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3f8b949c-4db5-4b1b-9004-e124baa3e051 61 fields · synced Jun 18, 2026