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NT-proBNP STAT (EECL)
EUDAMEDClass IVD General (EU MDR)
Ref 1042201000Model 25 tests/kitRef 1042202000Model 50 tests/kitRef 1042211000
Identity
- Device Name
- NT-proBNP STAT (EECL) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMED1042201000 EUDAMED50 tests/kit EUDAMED1042202000 EUDAMED1042211000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090500386 EUDAMED06975090501383 EUDAMED06975090502380 EUDAMED
- Basic UDI-DI
- B-06975090500386 EUDAMEDB-06975090501383 EUDAMEDB-06975090502380 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NT-proBNP STAT (EECL) by Accucise Diagnostics Inc. — 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-06975090500386 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 920b45a9-7153-4100-9c2d-d5887b65a058 61 fields · synced Jul 17, 2026
- EUDAMED e433b4a1-92d6-4432-8d85-10b3f8974cb3 61 fields · synced May 18, 2026
- EUDAMED 18a9a42f-e4e4-4664-8ef3-ba9f5a597dbf 61 fields · synced May 19, 2026