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LifeCycle for Prenatal Screening
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 5015-6000Ref 5015-0020Ref 5015-7000
by Wallac Oy
Identity
- Trade Name
- LifeCycle for Prenatal Screening EUDAMED
- Device Name
- LifeCycle for Prenatal Screening EUDAMED
- Model / Reference
- 5015-6000 EUDAMED5015-0020 EUDAMED5015-7000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147363100 EUDAMED06438147349609 EUDAMED06438147364510 EUDAMED
- Basic UDI-DI
- B-06438147363100 EUDAMEDB-06438147349609 EUDAMEDB-06438147364510 EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
LifeCycle for Prenatal Screening 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-06438147363100 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (3)
- EUDAMED 0f286f56-6fd4-4e0c-a47b-5243eb817038 61 fields · synced Jul 22, 2026
- EUDAMED 108b25f0-3cd7-4e6c-b27e-05e748cb5982 61 fields · synced May 17, 2026
- EUDAMED 8ebce64f-0f6b-47d4-9c1f-93bb05d8015a 61 fields · synced May 17, 2026