N-terminal pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence Method)
by Wuhan Easydiagnosis Biomedicine Co., Ltd.
Ref W-IF2-NT-proBNP-20Model 20 tests/kit, 40 tests/kit
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06978896415441 | Date27 Mar 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- 20 tests/kit, W-IF2-NT-proBNP-20, 40 tests/kit
- Primary DI / UDI-DI
- 06978896415441, 06978896415458
- Basic UDI-DI
- B-06978896415441, B-06978896415458
- EMDN Code
- W0102160704 Bnp / probnp - rt & poc (including other natriuric peptides)
- Device Class
- Class IVD General
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000019908
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No