N-terminal pro B-type Natriuretic Peptide Rapid Test Device - whole blood

EUDAMED

Class IVD General (EU MDR)

Ref B030501D

by Hangzhou Cybereagen Biotech Co., Ltd.

Identity

Trade Name: N-terminal pro B-type Natriuretic Peptide Rapid Test Device (serum/plasma/whole blood) EUDAMED
Model / Reference: B030501D EUDAMED

Identifiers

Primary DI / UDI-DI: 06976753475263 EUDAMED
Basic UDI-DI: B-06976753475263 EUDAMED
EMDN Code: W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
Models / Variants: serum EUDAMED
plasma EUDAMED
whole blood EUDAMED

Classification

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

Clinical & Handling

Sterile

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Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

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Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

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Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

N-terminal pro B-type Natriuretic Peptide Rapid Test Device - whole blood by Hangzhou Cybereagen Biotech Co., Ltd. — Class IVD General — IVDD — listed in…

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-06976753475263	Class IVD General	Active

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Manufacturer

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
EUDAMED SRN: CN-MF-000037850
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED a3374ffa-d537-4715-bff1-00a92e280170 61 fields · synced Jun 18, 2026