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N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence…
EUDAMEDClass IVD General (EU MDR)
Ref 18-02-0119Model 25 Tests/kitRef 18-02-0137Model 50 Tests/kitRef 100 Tests/kit（DR1076-2）Model 100 Tests/kitRef 50 Tests/kit（DR1076-1）
Identity
- Trade Name
- N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay) EUDAMEDN-terminal Pro Brain Natriuretic Peptide(NT-proBNP) Detection Kit(CLIA) EUDAMEDN-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence Immunoassay) EUDAMEDN-terminal Pro Brain Natriuretic Peptide(NT-proBNP) Detection Kit(CLIA) EUDAMEDN-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 25 Tests/kit EUDAMED18-02-0119 EUDAMED50 Tests/kit EUDAMED18-02-0137 EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1076-2） EUDAMED50 Tests/kit（DR1076-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674891728 EUDAMED06974674892657 EUDAMED06974969981738 EUDAMED06974969981165 EUDAMED
- Basic UDI-DI
- B-06974674891728 EUDAMEDB-06974674892657 EUDAMEDB-06974969981738 EUDAMEDB-06974969981165 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
N-terminal Pro Brain Natriuretic Peptide (NT-proBNP) Detection Kit(Fluorescence… by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-06974674891728 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED 100f4ce1-6388-498c-8dda-35d991daec26 61 fields · synced Oct 6, 2026
- EUDAMED f20fb1c7-4c15-4c13-914f-d8ea65122920 61 fields · synced May 19, 2026
- EUDAMED a4fbfa96-3aa6-49aa-b27d-936ab255b53b 61 fields · synced Jul 26, 2026
- EUDAMED 7e8e15ac-3294-4ad0-9a69-d825b29db97e 61 fields · synced Sep 18, 2026