← Back to catalogue
DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit
EUDAMEDFDA 510(k)Class IVD Annex II List B (EU MDR)
Ref B095-101510(k) K944490
by Wallac Oy
Identity
- Trade Name
- DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit EUDAMED
- Device Name
- DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit EUDAMED
- Model / Reference
- B095-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147355006 EUDAMED
- Basic UDI-DI
- B-06438147355006 EUDAMED
- EMDN Code
- W0102050203 UNCONJUGATED (FREE) ESTRIOL 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
DELFIA/AutoDELFIA Unconjugated Estriol (uE3) kit by Wallac Oy — Class IVD Annex II List B — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k)
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 | K944490 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147355006 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED d3137fc8-6d11-4328-a321-c29ae7b5a0fe 85 fields · synced Jun 18, 2026
- FDA 510(k) K944490 1 fields · synced May 18, 2026