Identity
- Trade Name
- QuikRead U-ALB EUDAMED
- Device Name
- QuikRead U-ALB EUDAMED
- Model / Reference
- 06014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115000853 EUDAMED
- Basic UDI-DI
- B-06438115000853 EUDAMED
- EMDN Code
- W0102010309 ALBUMIN (IC) INCL. UALBUMIN 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
QuikRead U-ALB 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-06438115000853 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (1)
- EUDAMED d29af561-20ee-4808-a4a4-4737722654ab 61 fields · synced Jul 30, 2026