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AutoDELFIA hAFP/Free hCGß Dual
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref B067-101
by Wallac Oy
Identity
- Trade Name
- AutoDELFIA hAFP/Free hCGß Dual EUDAMED
- Device Name
- AutoDELFIA hAFP/Free hCGß Dual EUDAMED
- Model / Reference
- B067-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147009602 EUDAMED
- Basic UDI-DI
- B-06438147009602 EUDAMED
- EMDN Code
- W0102050299 PREGNANCY TESTING HORMONES - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland 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
AutoDELFIA hAFP/Free hCGß Dual by Wallac Oy — Class IVD Annex II List B — 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-06438147009602 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (1)
- EUDAMED 615efcc5-965c-4c2c-84f4-7f831c9edf5b 61 fields · synced Jun 18, 2026