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NT-proBNP Rapid Quantitative Test

by Coei Biotech Co.Ltd.

Ref 0742Model 25 servings/box, 20 boxes/carton

NT-proBNP Rapid Quantitative Test (0742) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category bnp / probnp (including other natriuric peptides)) made by Coei Biotech Co.Ltd., registered in EUDAMED on 11 Apr 2026 (Basic UDI-DI B-06977565580749), active as of 22 Oct 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977565580749 Basic UDI-DI Date11 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
25 servings/box, 0742, 20 boxes/carton
Primary DI / UDI-DI
06977565580749, 16977565580746
Basic UDI-DI
B-06977565580749, B-16977565580746
EMDN code
W01021301 Bnp / probnp (including other natriuric peptides)
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000049509
Authorised representative
Medunion S.L. ES-AR-000019366

Similar devices in this category

Other devices filed under BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES).

Other devices from Coei Biotech Co.Ltd.

See all devices from Coei Biotech Co.Ltd. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)