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Functional Fibrinogen Assay
EUDAMEDClass IVD General (EU MDR)
Ref MCT00603ERef MCT00602ERef MCT00601E
Identity
- Trade Name
- Functional Fibrinogen Assay EUDAMED
- Device Name
- Functional Fibrinogen Assay EUDAMED
- Model / Reference
- MCT00603E EUDAMEDMCT00602E EUDAMEDMCT00601E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604809 EUDAMED06926802604793 EUDAMED06926802603802 EUDAMED
- Basic UDI-DI
- B-06926802604809 EUDAMEDB-06926802604793 EUDAMEDB-06926802603802 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Functional Fibrinogen Assay by Medcaptain Medical Technology 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-06926802604809 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (3)
- EUDAMED 4bd92faf-d99b-4113-9cff-767c065c72f4 61 fields · synced Jul 14, 2026
- EUDAMED 3422cb2c-3211-4ae8-b052-9ca7dd38df87 61 fields · synced May 18, 2026
- EUDAMED 3f1ab504-5e10-4404-80bb-1c7a9dbdd17f 61 fields · synced May 18, 2026