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QuikRead CRP with prefilled cuvettes
EUDAMEDClass IVD General (EU MDR)
Ref 134192Ref 134191
by Aidian Oy
Identity
- Trade Name
- QuikRead CRP with prefilled cuvettes EUDAMED
- Device Name
- QuikRead CRP with prefilled cuvettes EUDAMED
- Model / Reference
- 134192 EUDAMED134191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115000730 EUDAMED06438115000723 EUDAMED
- Basic UDI-DI
- B-06438115000730 EUDAMEDB-06438115000723 EUDAMED
- EMDN Code
- W0102160601 C-REACTIVE PROTEIN - 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
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 CRP with prefilled cuvettes 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-06438115000730 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED 7ad5c2ec-9f36-4f74-ac06-554bd372ed48 61 fields · synced Jul 27, 2026
- EUDAMED faa0be82-8923-4791-9629-d556765b445f 61 fields · synced May 19, 2026