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Blood Collection Kit

by Epimune GmbH EUDAMED

Active European Union

Ref BCK-01

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42700013202BCK-012Y Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
BCK-01
Primary DI / UDI-DI
04270003842303
Basic UDI-DI
42700013202BCK-012Y
EMDN Code
A99 Devices for administration, withdrawal and collection - other
Device Class
Class IIa
Medical Purpose
This procedure pack contains materials required for the collection of a venous blood sample to be taken by a professional user.

Manufacturer details

EUDAMED SRN
DE-PR-000046751

Other devices from Epimune GmbH

Properties

Other properties (1)

  • Sterile: No