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B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/KitModel 50 Tests/KitRef 100 Tests/KitRef CA1602AModel 2×50 test/box Calibrator:0.5mL×2
Identity
- Trade Name
- B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 50 Tests/Kit EUDAMED100 Tests/Kit EUDAMED2×50 test/box Calibrator:0.5mL×2 EUDAMEDCA1602A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813395 EUDAMED06974986813401 EUDAMED06970522649183 EUDAMED
- Basic UDI-DI
- B-06974986813395 EUDAMEDB-06974986813401 EUDAMEDB-06970522649183 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
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
B-type Natriuretic Peptide (BNP) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…
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-06974986813395 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 39251c82-9f52-4b62-8da8-b238664283be 61 fields · synced Oct 6, 2026
- EUDAMED 30ccc904-73de-4338-a214-99cd4170f17d 61 fields · synced May 18, 2026
- EUDAMED 2365a931-8ede-4da2-905a-60ad9a260c1e 61 fields · synced Jul 9, 2026