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Vacuette 450210

by Greiner Bio - One GmbH

Ref 450210Model VACUETTE® SAFELINK

Vacuette 450210 is a device classified as Class I in the EU and Class II in the US made by Greiner Bio - One GmbH, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 912001757G0000083A5), cleared under FDA 510(k) K180545 on 21 May 2018 and listed in FDA GUDID since 14 Nov 2018 (UDI-DI 19120049207487), active as of 24 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180545

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/MDR EUDAMED Number912001757G0000083A5 Basic UDI-DI 19120049207487UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120049207487 UDI-DI Date14 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180545 Date21 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 912001757G0000083A5 registered 24 Jul 2026 Active
  • FDA 510(k) K180545 decided 21 May 2018 Active
  • FDA GUDID UDI-DI 19120049207487 listed 14 Nov 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0802-2025 FDA Class II initiated 19 Nov 2024

    The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

Timeline

4 dated events

  1. Cleared FDA 510(k) K180545
  2. Listed FDA GUDID 19120049207487
  3. Recall initiated FDA recalls Z-0802-2025
  4. Registered EUDAMED 912001757G0000083A5

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  • Withdrawn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® SAFELINK Holder with male luer lock single-packed, not made with natural rubber latex EUDAMED
Vacuette GUDID
Generic name
Luer-ended blood collection tube spike
Model / Ref / Catalog
450210, VACUETTE® SAFELINK
Primary DI / UDI-DI
19120049207487
Basic UDI-DI
912001757G0000083A5
510(k) Number
FDA product code
FMI
EMDN code
A070199 Adapters and connectors - other
GMDN term
Luer-ended blood collection tube spike
Device class
Class I 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 I
GUDID
Class II

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: Luer-ended blood collection tube spike

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)