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Actim® PROM 1ngeni Test
EUDAMEDClass IVD General (EU MDR)
Ref 30832RETAL
by Actim Oy
Identity
- Trade Name
- Actim® PROM 1ngeni Test EUDAMED
- Device Name
- Actim® PROM 1ngeni Test EUDAMED
- Model / Reference
- 30832RETAL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6430030990561U6 EUDAMED
- Basic UDI-DI
- B-6430030990561U6 EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Actim® PROM 1ngeni Test by Actim Oy — Class IVD General — 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-6430030990561U6 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Actim Oy
- EUDAMED SRN
- FI-MF-000024323
Sources (1)
- EUDAMED 62455860-0f0d-4c99-900a-722b14cb3a40 61 fields · synced Jul 25, 2026