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Actim® Calprotectin Controls
EUDAMEDClass IVD General (EU MDR)
Ref 35000ETAC
by Actim Oy
Identity
- Trade Name
- Actim® Calprotectin Controls EUDAMED
- Device Name
- Actim® Calprotectin Controls EUDAMED
- Model / Reference
- 35000ETAC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6430030990691UL EUDAMED
- Basic UDI-DI
- B-6430030990691UL EUDAMED
- EMDN Code
- W0102160801 CONTROLS IMMUNOCHEM - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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® Calprotectin Controls 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-6430030990691UL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Actim Oy
- EUDAMED SRN
- FI-MF-000024323
Sources (1)
- EUDAMED c7ee2e20-c6b3-41c1-9429-10a5360e652a 61 fields · synced Jun 18, 2026