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Actim® Fecal Blood
EUDAMEDClass IVD General (EU MDR)
Ref 30331ETACRef 30361ETAC
by Actim Oy
Identity
- Trade Name
- Actim® Fecal Blood EUDAMEDActim® Fecal Blood dipsticks EUDAMED
- Device Name
- Actim® Fecal Blood EUDAMEDActim® Fecal Blood dipsticks EUDAMED
- Model / Reference
- 30331ETAC EUDAMED30361ETAC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6430030990011SW EUDAMEDD-6430030990028TF EUDAMED
- Basic UDI-DI
- B-6430030990011SW EUDAMEDB-6430030990028TF EUDAMED
- EMDN Code
- W0102160203 FECAL OCCULT BLOOD - 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
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® Fecal Blood 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-6430030990011SW | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Actim Oy
- EUDAMED SRN
- FI-MF-000024323
Sources (2)
- EUDAMED a2dae972-e2ba-4be2-83a5-8648a72ab610 61 fields · synced Jul 26, 2026
- EUDAMED a1919f0a-ae1f-41e6-9836-0f43a20b9882 61 fields · synced May 18, 2026