← Back to catalogue

BNP Fast Test Kit (Immunofluorescence Assay)

EUDAMED

Class IVD General (EU MDR)

Ref /Ref IF5089 

by Getein Biotech, Inc.

Identity

Trade Name
BNP Fast Test Kit (Immunofluorescence Assay) EUDAMED
BNP Fast Test Kit (Immunofluorescence Assay) EUDAMED
Device Name
BNP Fast Test Kit (Immunofluorescence Assay) EUDAMED
BNP Fast Test Kit (Immunofluorescence Assay) EUDAMED
Model / Reference
/ EUDAMED
IF5089 EUDAMED

Identifiers

Primary DI / UDI-DI
06954414702736 EUDAMED
06954414722109 EUDAMED
Basic UDI-DI
B-06954414702736 EUDAMED
695441470273HH EUDAMED
EMDN Code
W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class C EUDAMED
Market of Registration
Netherlands EUDAMED
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

BNP Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/IVDD

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

Manufacturer

Manufacturer
Getein Biotech, Inc.
EUDAMED SRN
CN-MF-000017986
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED b6298d52-5994-49ea-b0e5-8c02bd841bcd 61 fields · synced Jul 15, 2026
  • EUDAMED b9a6dd9f-b3e8-4035-925f-d0496d34d90e 61 fields · synced Jul 15, 2026