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NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref NT-proBNP706-AE10Y, NT-proBNP706-AE10N, NT-proBNP706-AE20Y, NT-proBNP706-AE20N
Identity
- Trade Name
- NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA) EUDAMED
- Device Name
- NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA) EUDAMED
- Model / Reference
- NT-proBNP706-AE10Y, NT-proBNP706-AE10N, NT-proBNP706-AE20Y, NT-proBNP706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-NT-proBNP706-AE3K EUDAMED
- Basic UDI-DI
- B-NT-proBNP706-AE3K 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NT-proBNP N-Terminal Pro-Brain Natriuretic Peptide (CLIA) by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-NT-proBNP706-AE3K | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 6cb10d83-b77f-4b56-946c-847b22d9c85f 61 fields · synced Oct 6, 2026
- EUDAMED 6cb10d83-b77f-4b56-946c-847b22d9c85f-1 61 fields · synced Jun 9, 2026