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Newfoundland
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 880080-1
by PRIMA Lab SA
Identity
- Trade Name
- Newfoundland EUDAMED
- Device Name
- Newfoundland Prostate Health test EUDAMED
- Model / Reference
- 880080-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640164860084 EUDAMED
- Basic UDI-DI
- B-07640164860084 EUDAMED
- EMDN Code
- W0102160202 PSA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Newfoundland by PRIMA Lab SA — 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-07640164860084 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- PRIMA Lab SA
- EUDAMED SRN
- CH-MF-000034473
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED dcbc2fa9-25ae-47ba-bec5-ac78cd40552d 61 fields · synced Jul 25, 2026