Identity
- Trade Name
- FDP (CLIA) EUDAMED
- Device Name
- FDP (CLIA) EUDAMED
- Model / Reference
- MCL04002E EUDAMEDMCL04001E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604496 EUDAMED06926802604489 EUDAMED
- Basic UDI-DI
- B-06926802604496 EUDAMEDB-06926802604489 EUDAMED
- EMDN Code
- W0103020502 FIBRINOGEN DEGRADATION PRODUCTS 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
Fdp (clia) 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-06926802604496 | 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 (2)
- EUDAMED 6078380e-1d18-48ae-91c4-4b08223a6585 61 fields · synced Jul 29, 2026
- EUDAMED 676bd250-f179-4d88-a0bb-ce36cb2d1136 61 fields · synced May 18, 2026