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CRP (C-reactive protein) Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 1642Model 25 servings/boxModel 20 boxes/carton
Identity
- Trade Name
- CRP (C-reactive protein) Rapid Quantitative Test EUDAMED
- Device Name
- CRP (C-reactive protein) Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED1642 EUDAMED20 boxes/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565581647 EUDAMED16977565581644 EUDAMED
- Basic UDI-DI
- B-06977565581647 EUDAMEDB-16977565581644 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
CRP (C-reactive protein) Rapid Quantitative Test by Coei Biotech Co.Ltd. — 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-06977565581647 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 3d762bf3-c8b9-4c31-b82b-e71612439971 61 fields · synced Jul 24, 2026
- EUDAMED c3782bc2-386e-4bcb-86a1-57aa01496bcf 61 fields · synced Jul 24, 2026