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N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit (Fluorescence Im…
EUDAMEDClass IVD General (EU MDR)
Ref /Ref A5403CCRef A5403CVRef A5404CCRef 10tests/kitRef Ir081Ref A5402CL
Identity
- Trade Name
- N-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Device Name
- N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMEDN-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMEDN-terminal pro-B-type natriuretic peptide (NT-proBNP)Test Kit EUDAMEDNT-proBNP N-Terminal Pro-B-Type Natriuretic Peptide Test Kit EUDAMED
- Model / Reference
- / EUDAMEDA5403CC EUDAMEDA5403CV EUDAMEDA5404CC EUDAMED10tests/kit EUDAMEDIr081 EUDAMEDA5402CL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K90411-003P3 EUDAMED06979469760845 EUDAMED06973315738774 EUDAMED06979469760852 EUDAMED06978189071118 EUDAMEDD-697994388Ir0813NEA EUDAMED06979469760838 EUDAMED
- Basic UDI-DI
- B-K90411-003P3 EUDAMEDB-06979469760845 EUDAMEDB-06973315738774 EUDAMEDB-06979469760852 EUDAMEDB-06978189071118 EUDAMEDB-697994388Ir0813NEA EUDAMEDB-06979469760838 EUDAMED
- EMDN Code
- W0102160704 BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMEDW01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMEDW0102160701 CREATINE KINASE - MB MASS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit (Fluorescence Im… by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-K90411-003P3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (7)
- EUDAMED e17ded77-230c-4541-b675-d6879e0a4665 61 fields · synced Sep 18, 2026
- EUDAMED d40fd744-82ff-4257-9d77-d883616db5a5 61 fields · synced Jun 18, 2026
- EUDAMED 7411a545-ec08-4045-a4fa-87829420192a 61 fields · synced Jul 9, 2026
- EUDAMED 85f6dd65-dfba-49da-8d04-bf05f93009f6 61 fields · synced Jul 20, 2026
- EUDAMED 4949b6e6-8121-4db2-82c3-8fbc76c9796b 61 fields · synced Jul 30, 2026
- EUDAMED 2b48cc32-0fd3-4eb5-8f88-f8e74729395f 61 fields · synced Aug 4, 2026
- EUDAMED eff486e9-5015-44db-ab17-fde95d133421 61 fields · synced Sep 18, 2026