Identity
- Trade Name
- H-FABP (CLIA) EUDAMED
- Device Name
- H-FABP (CLIA) EUDAMED
- Model / Reference
- MCL03902E EUDAMEDMCL03901E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604472 EUDAMED06926802604465 EUDAMED
- Basic UDI-DI
- B-06926802604472 EUDAMEDB-06926802604465 EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
H-Fabp (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-06926802604472 | 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 3abf8ed7-79ec-4bac-bbbb-28e611ce5fd6 61 fields · synced Jul 28, 2026
- EUDAMED 71aaaa24-95c4-4a01-a3e8-c35aa351603b 61 fields · synced May 18, 2026