Amino Terminal pro Brain Natriuretic Peptide Rapid Test Kit(FIA)

EUDAMED

Class IVD General (EU MDR)

Ref 25Tests/kit

by Beijing Kewei Clinical Diagnostic Reagent Inc

Identity

Device Name: Amino Terminal pro Brain Natriuretic Peptide Rapid Test Kit(FIA) EUDAMED
Model / Reference: 25Tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI: 06970664751935 EUDAMED
Basic UDI-DI: B-06970664751935 EUDAMED
EMDN Code: W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Amino Terminal pro Brain Natriuretic Peptide Rapid Test Kit(FIA) by Beijing Kewei Clinical Diagnostic Reagent 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-06970664751935	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc
EUDAMED SRN: CN-MF-000019125
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED b2876817-b4d5-48c5-acb1-46aaabac671c 61 fields · synced Jul 26, 2026