← Back to catalogue
Innodx Bnp Stat Cmia
EUDAMEDClass C (EU MDR)
Ref KR-BNP STAT-0450Ref KR-BNP STAT-04100Ref KR-BNP STAT-0250Ref KR-BNP STAT-02100Ref KR-BNP STAT-02200
Identity
- Trade Name
- INNODX BNP STAT CMIA EUDAMED
- Device Name
- INNODX BNP STAT CMIA EUDAMED
- Model / Reference
- KR-BNP STAT-0450 EUDAMEDKR-BNP STAT-04100 EUDAMEDKR-BNP STAT-0250 EUDAMEDKR-BNP STAT-02100 EUDAMEDKR-BNP STAT-02200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799190 EUDAMED06973600799206 EUDAMED06973600799176 EUDAMED06973600798162 EUDAMED06973600799183 EUDAMEDD-KR-BNPSTAT-02506J EUDAMEDD-KR-BNPSTAT-02200WD EUDAMED
- Basic UDI-DI
- 697360079029K7 EUDAMEDB-KR-BNPSTAT-02506J EUDAMEDB-KR-BNPSTAT-02200WD 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 Bnp 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 | 697360079029K7 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079029K7 | 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 (7)
- EUDAMED 1598a683-30c6-401b-9bd9-dfe96f7978b4 61 fields · synced Oct 7, 2026
- EUDAMED 52ecde87-5818-4f90-9492-7e31b3e452a7 61 fields · synced May 17, 2026
- EUDAMED 9d8e86c5-1a6d-483f-a6be-a34e3d2d4052 61 fields · synced May 18, 2026
- EUDAMED d65bdf92-b8ca-40b7-a4d6-550d277f127c 61 fields · synced May 18, 2026
- EUDAMED 8409f436-32e6-4849-93a0-89b1e40ff373 61 fields · synced May 18, 2026
- EUDAMED 928ae880-5713-41d7-b2ac-4eaf67803713 61 fields · synced Jul 10, 2026
- EUDAMED c3e71eb9-01aa-4bc7-9505-3f1eb3221a5e 61 fields · synced Aug 2, 2026