Identity
- Trade Name
- QuikRead iFOB Sampling Set EUDAMED
- Device Name
- QuikRead iFOB Sampling Set EUDAMED
- Model / Reference
- 151052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115001294 EUDAMED
- Basic UDI-DI
- 6438115QRiFOBSamplSetNT EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
New Device
No
EUDAMED
QuikRead iFOB Sampling Set by Aidian 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 | 6438115QRiFOBSamplSetNT | Class A | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (1)
- EUDAMED 86e7cbc3-15fc-4245-934a-c5d44cec3123 61 fields · synced Jun 19, 2026