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Actim 1ngeni Instrument Check
EUDAMEDClass A (EU MDR)
Ref 19116ICRef 19101AC
by Actim Oy
Identity
- Trade Name
- Actim 1ngeni Instrument Check EUDAMEDActim 1ngeni EUDAMED
- Device Name
- Actim 1ngeni Instrument Check EUDAMEDActim 1ngeni EUDAMED
- Model / Reference
- 19116IC EUDAMED19101AC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430030990844 EUDAMED06430030990837 EUDAMED
- Basic UDI-DI
- 643003099ACTIM191165Y EUDAMED643003099ACTIM191015K EUDAMED
- Direct Marketing DI
- 06430030990844 EUDAMED06430030990837 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMEDNetherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Actim 1ngeni Instrument Check by Actim Oy — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 643003099ACTIM191165Y | Class A | Active |
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Manufacturer
- Manufacturer
- Actim Oy
- EUDAMED SRN
- FI-MF-000024323
Sources (2)
- EUDAMED 1943142b-d721-4591-9c5b-5e19cce6bee1 61 fields · synced Jul 13, 2026
- EUDAMED fa31a7ca-48d6-42b5-bc84-b3cccad3986e 61 fields · synced May 18, 2026