← Back to catalogue
DELFIA Xpress PlGF 1-2-3
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 6007-005CRef 6007-003CRef 6007-0030
by Wallac Oy
Identity
- Trade Name
- DELFIA Xpress PlGF 1-2-3 EUDAMED
- Device Name
- DELFIA Xpress PlGF 1-2-3 EUDAMED
- Model / Reference
- 6007-005C EUDAMED6007-003C EUDAMED6007-0030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147386314 EUDAMED06438147335312 EUDAMED06438147335305 EUDAMED
- Basic UDI-DI
- B-06438147386314 EUDAMEDB-06438147335312 EUDAMEDB-06438147335305 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Xpress PlGF 1-2-3 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-06438147386314 | 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 (3)
- EUDAMED dfb57fc4-7a6e-4535-8e2f-fc67aec90904 61 fields · synced Jul 18, 2026
- EUDAMED 8f36cac7-830b-413f-83d8-a78ecdd05365 61 fields · synced May 18, 2026
- EUDAMED ebe078ae-07c1-4ee2-8df3-21fb82ac65d0 61 fields · synced May 18, 2026