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Vacuette 450239V1

by Greiner Bio - One GmbH

Ref 450239V1Model VACUETTE® QUICKSHIELD Complete PLUS

Vacuette 450239V1 is a device classified as Class IIa in the EU and Class II in the US made by Greiner Bio - One GmbH, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 912001757G00000819Z), cleared under FDA 510(k) K072320 on 14 Sep 2007 and listed in FDA GUDID since 6 Aug 2019 (UDI-DI 19120049209030), active as of 23 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072320

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/MDR EUDAMED Number912001757G00000819Z Basic UDI-DI 19120049209030UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120049209030 UDI-DI Date6 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK072320 Date14 Sep 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 912001757G00000819Z registered 29 Jul 2026 Active
  • FDA 510(k) K072320 decided 14 Sep 2007 Active
  • FDA GUDID UDI-DI 19120049209030 listed 6 Aug 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1935-2012 FDA Class II initiated 2 Apr 2012

    : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.

Timeline

4 dated events

  1. Cleared FDA 510(k) K072320
  2. Recall initiated FDA recalls Z-1935-2012
  3. Listed FDA GUDID 19120049209030
  4. Registered EUDAMED 912001757G00000819Z

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
VACUETTE® QUICKSHIELD Complete PLUS 21G x 1 1/2" single-packed, sterile 0.80 x 38 mm EUDAMED
Vacuette GUDID
Generic name
Blood collection tube holder/needle
Model / Ref / Catalog
450239V1, VACUETTE® QUICKSHIELD Complete PLUS
Primary DI / UDI-DI
19120049209030
Basic UDI-DI
912001757G00000819Z
510(k) Number
FDA product code
FMI
EMDN code
A01010501 Needles for collection under vacuum, with safety systems
GMDN term
Blood collection tube holder/needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5570
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Blood collection tube holder/needle

Cleared under the same submission (K072320)

Similar devices in this category

Other devices filed under NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS.

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)