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Mixject 9070101

by West Pharma. Services Il, . Ltd

Ref 9070101

Mixject 9070101 is a device classified as Class IIa in the EU and Class II in the US made by West Pharma. Services Il, . Ltd, registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI B-07290108240948), cleared under FDA 510(k) K963583 on 7 Oct 1996 and listed in FDA GUDID since 1 May 2016 (UDI-DI 07290108240948), active as of 23 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 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290108240948 Basic UDI-DI 07290108240948UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108240948 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-07290108240948 registered 27 Jul 2026 Active
  • FDA 510(k) K963583 decided 7 Oct 1996 Active
  • FDA GUDID UDI-DI 07290108240948 listed 1 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K963583
  2. Listed FDA GUDID 07290108240948
  3. Registered EUDAMED B-07290108240948

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  • Withdrawn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
MixJect® EUDAMED
Mixject GUDID
Generic name
Medication transfer set
Model / reference
9070101
Primary DI / UDI-DI
07290108240948
Basic UDI-DI
B-07290108240948
510(k) Number
FDA product code
LHI
EMDN code
A019099 Needles for other procedures - other
GMDN term
Medication transfer set
Device class
Class IIa 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 IIa
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 07290108240948: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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: Medication transfer set

Cleared under the same submission (K963583)

and 8 more cleared under K963583

Similar devices in this category

Other devices filed under NEEDLES FOR OTHER PROCEDURES - OTHER.

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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)