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Vial Adapter 8072036

by West Pharma. Services Il, . Ltd EUDAMEDGUDID

Expiring European Union

Ref 8072036

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3902869CE01 Date6 Jul 2026IssuedStatusExpiring expires 1 Aug 2027
European UnionCE/MDD EUDAMED Number729010824VAT4 Basic UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108240092 UDI-DIDate1 May 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Expiring
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3902869CE01 Expiring Amended Expires in 277 days

    Quality management system EU MDR

    Notified body
    0344
    Issued
    6 Jul 2026
    Expires
    1 Aug 2027
    Reason
    Other

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Vial Adapter
Generic Name
Vial/bottle adaptor, non-hermetic
Device Name
Vial Adapter™
Model / Reference
8072036
Primary DI / UDI-DI
07290108240092
Basic UDI-DI
729010824VAT4, B-07290108240092
510(k) Number
FDA Product Code
LHI
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
GMDN Term
Vial/bottle adaptor, non-hermetic
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5440
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K001293)

Show all (12)

Other devices from West Pharma. Services IL, Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No