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Vial Adaptor 8070211

by West Pharma. Services Il, . Ltd

Ref 8070211

Vial Adaptor 8070211 is a device classified as Class I in the EU and Class II in the US made by West Pharma. Services Il, . Ltd, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI B-07290108240481), cleared under FDA 510(k) K963583 on 7 Oct 1996 and listed in FDA GUDID since 1 May 2016 (UDI-DI 07290108240481), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K963583

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108240481 Basic UDI-DI 07290108240481UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108240481 UDI-DI Date1 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK963583 Date7 Oct 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290108240481 registered 2 Jul 2026 Active
  • FDA 510(k) K963583 decided 7 Oct 1996 Active
  • FDA GUDID UDI-DI 07290108240481 listed 1 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K963583
  2. Listed FDA GUDID 07290108240481
  3. Registered EUDAMED B-07290108240481

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vial Adaper EUDAMED
Vial Adaptor GUDID
Generic name
Vial/bottle adaptor, non-hermetic
Device name
Vial Adapter™
Model / reference
8070211
Primary DI / UDI-DI
07290108240481
Basic UDI-DI
B-07290108240481
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
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07290108240481: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vial/bottle adaptor, non-hermetic

Cleared under the same submission (K963583)

and 8 more cleared under K963583

Similar devices in this category

Other devices filed under SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS.

Other devices from West Pharma. Services IL, Ltd.

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

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)