Identity
- Trade Name
- H-FABP Test Kit FIA EUDAMED
- Device Name
- H-FABP Test Kit FIA EUDAMED
- Model / Reference
- H-FABP-D06a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-H-FABP-D06aBK EUDAMED
- Basic UDI-DI
- B-H-FABP-D06aBK EUDAMED
- EMDN Code
- W0102160705 HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC 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
H-FABP Test Kit FIA by Hangzhou Aichek 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-H-FABP-D06aBK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 17595233-87dc-41dc-83c8-fac501e96555 61 fields · synced Jun 18, 2026