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hsCRP Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 0442Model 25 servings/boxRef 0542
Identity
- Trade Name
- hsCRP Rapid Quantitative Test EUDAMED
- Device Name
- hsCRP Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED0442 EUDAMED0542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565580442 EUDAMED16977565580449 EUDAMED26977565580446 EUDAMED
- Basic UDI-DI
- B-06977565580442 EUDAMEDB-16977565580449 EUDAMEDB-26977565580446 EUDAMED
- EMDN Code
- W01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN EUDAMEDW0103020503 D-DIMER 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
hsCRP 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-06977565580442 | 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 (3)
- EUDAMED ade97b02-7a90-4bf4-8fc8-59f8d6586f36 61 fields · synced Jul 14, 2026
- EUDAMED 3d213903-4e3e-4127-ad17-150a9e9cad3d 61 fields · synced Jul 11, 2026
- EUDAMED 410bd4b5-5bca-4501-b86c-53c75b298483 61 fields · synced Jul 13, 2026