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N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit(Immunofluorescenc…
EUDAMEDClass IVD General (EU MDR)
Ref 52027001Model 50T/KitRef 2211Ref 52026001Model 25T/kitRef W-IF2-NT-proBNP-20 Model 20 tests/kitModel 40 tests/kit
Identity
- Trade Name
- N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence) EUDAMEDN-terminal pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence Method) EUDAMED
- Device Name
- N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit(Immunofluorescence) EUDAMEDN-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence) EUDAMEDN-terminal pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 50T/Kit EUDAMED52027001 EUDAMED2211 EUDAMED25T/kit EUDAMED52026001 EUDAMED20 tests/kit EUDAMEDW-IF2-NT-proBNP-20 EUDAMED40 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FA0014Z3 EUDAMED06978198482110 EUDAMED06950334804475 EUDAMED06978896415441 EUDAMED06978896415458 EUDAMED
- Basic UDI-DI
- B-FA0014Z3 EUDAMEDB-06978198482110 EUDAMEDB-06950334804475 EUDAMEDB-06978896415441 EUDAMEDB-06978896415458 EUDAMED
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMEDW0102160704 BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMEDGermany EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit(Immunofluorescenc… by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-FA0014Z3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 5984af0a-3fb6-4b3e-a8d7-63551f1e4e7a 61 fields · synced Jul 30, 2026
- EUDAMED 9e1fd89f-6c2a-4d32-ab7d-90385e6fb62c 61 fields · synced May 17, 2026
- EUDAMED cfcd135d-6034-4125-80aa-53ff0a4fcb09 61 fields · synced May 17, 2026
- EUDAMED 2ee0d058-a0c1-4038-a88a-36f90aa11d5c 61 fields · synced May 17, 2026
- EUDAMED b43103bd-d51e-45e3-9f42-b2136fbda983 61 fields · synced May 19, 2026