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Mix2Vial®

by West Pharma. Services IL, Ltd. EUDAMED

Active European Union

Ref 8074043

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number729010824M2VCR14H Basic UDI-DIDate4 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3902869CE02 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    30 Jun 2026
    Expires
    1 Feb 2030
    Reason
    Other

Specification

EUDAMED

Model / Reference
8074043
Primary DI / UDI-DI
07290108241907
Basic UDI-DI
729010824M2VCR14H
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IL-MF-000008572
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from West Pharma. Services IL, Ltd.

See all devices from West Pharma. Services IL, Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No