Identity
- Trade Name
- INNODX NBNP STAT CMIA EUDAMED
- Device Name
- INNODX NBNP STAT CMIA EUDAMED
- Model / Reference
- KR-NBNP-03100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600798841 EUDAMED
- Basic UDI-DI
- 697360079027K3 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium 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 — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697360079027K3 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED e8129a21-bede-4acd-a3e9-b8abefc15945 61 fields · synced Jun 19, 2026