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QuikRead FOB Positive Control
EUDAMEDClass IVD General (EU MDR)
Ref 06027
by Aidian Oy
Identity
- Trade Name
- QuikRead FOB Positive Control EUDAMED
- Device Name
- QuikRead FOB Positive Control EUDAMED
- Model / Reference
- 06027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115000846 EUDAMED
- Basic UDI-DI
- B-06438115000846 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
Yes
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
QuikRead FOB Positive Control by Aidian 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-06438115000846 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (1)
- EUDAMED a110d6cf-876f-4835-bc30-3225cec09931 61 fields · synced Jul 26, 2026