Innodx Nbnp Stat Cmia
by Xiamen Innodx Biotech Co., Ltd. 5 variants
Ref KR-NBNP STAT-0250
Active
CE IVDR CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number697360079027K3 | Date5 May 2026 | StatusActive |
| European Union | CE/IVDR | Number697360079027K3 | Date5 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Model / Reference
- KR-NBNP STAT-0250
- Primary DI / UDI-DI
- 06973600799589, D-KR-NBNPSTAT-0250A8
- Basic UDI-DI
- 697360079027K3, B-KR-NBNPSTAT-0250A8
- EMDN Code
- W01021301 Bnp / probnp (including other natriuric peptides)
- Device Class
- Class CClass IVD General
- EU market of registration
- BelgiumSpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000041071
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Xiamen Innodx Biotech Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No