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Innodx Nbnp Stat Cmia
EUDAMEDClass C (EU MDR)
Ref KR-NBNP STAT-02200Ref KR-NBNP STAT-0250Ref KR-NBNP STAT-02100Ref KR-NBNP STAT-0350
Identity
- Trade Name
- INNODX NBNP STAT CMIA EUDAMED
- Device Name
- INNODX NBNP STAT CMIA EUDAMED
- Model / Reference
- KR-NBNP STAT-02200 EUDAMEDKR-NBNP STAT-0250 EUDAMEDKR-NBNP STAT-02100 EUDAMEDKR-NBNP STAT-0350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799596 EUDAMED06973600799589 EUDAMED06973600799619 EUDAMED06973600799602 EUDAMEDD-KR-NBNPSTAT-0250A8 EUDAMEDD-KR-NBNPSTAT-022008A EUDAMED
- Basic UDI-DI
- 697360079027K3 EUDAMEDB-KR-NBNPSTAT-0250A8 EUDAMEDB-KR-NBNPSTAT-022008A EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Belgium EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Innodx Nbnp Stat Cmia by Xiamen Innodx Biotech Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697360079027K3 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079027K3 | Class C | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (6)
- EUDAMED d92209fc-a7db-4638-aebc-c1c4e7c599ae 61 fields · synced Oct 6, 2026
- EUDAMED b702cd1c-f928-423a-9bd5-bd997530c805 61 fields · synced May 17, 2026
- EUDAMED 6d4a4828-3119-4cea-89fd-d76589286e2b 61 fields · synced May 18, 2026
- EUDAMED 7bb5a334-4ed2-48c2-925a-29cdd7d2a5c5 61 fields · synced May 18, 2026
- EUDAMED edb22306-5450-4064-b367-167eed3da462 61 fields · synced Jul 11, 2026
- EUDAMED 2505ba98-c4b8-4fe6-a696-0b3b9aaa4b10 61 fields · synced Jul 14, 2026