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NT-proBNP Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 0742Model 25 servings/boxModel 20 boxes/carton
Identity
- Trade Name
- NT-proBNP Rapid Quantitative Test EUDAMED
- Device Name
- NT-proBNP Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED0742 EUDAMED20 boxes/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565580749 EUDAMED16977565580746 EUDAMED
- Basic UDI-DI
- B-06977565580749 EUDAMEDB-16977565580746 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) 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
NT-proBNP 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-06977565580749 | 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 5de19a9b-0793-4ced-9d8d-0a52d21cb43c 61 fields · synced Jul 25, 2026
- EUDAMED cd42d91e-5112-4042-8b19-36b48583b9a3 61 fields · synced Jul 25, 2026