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AutoDELFIA hCG
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref B082-101
by Wallac Oy
Identity
- Trade Name
- AutoDELFIA hCG EUDAMED
- Device Name
- AutoDELFIA hCG EUDAMED
- Model / Reference
- B082-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147121540 EUDAMED
- Basic UDI-DI
- B-06438147121540 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN 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 hCG by Wallac Oy — Class IVD Annex II List B — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K935047 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147121540 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED d7cc2b42-1e23-4fc5-9ddd-7f5e4a7901fd 61 fields · synced Jul 25, 2026
- FDA 510(k) K935047 1 fields · synced May 18, 2026