Identity
- Trade Name
- Facit hCG EUDAMED
- Device Name
- Facit hCG EUDAMED
- Model / Reference
- 149737 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115001201 EUDAMED
- Basic UDI-DI
- B-06438115001201 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Facit hCG by Aidian Oy — 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-06438115001201 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (1)
- EUDAMED 7c06cd37-40e0-4c55-b576-685eabea4d6e 61 fields · synced Jul 12, 2026