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Vacuette 450185

by Greiner Bio - One GmbH

Ref 450185Model SAFETY Blood Collection Sets + Blood Culture Holder

Vacuette 450185 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 24 Jul 2026 (Basic UDI-DI 912001757G0000078AC), cleared under FDA 510(k) K122687 on 10 Jan 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 19120017577727), active as of 24 Oct 2026.

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122687

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 Number912001757G0000078AC Basic UDI-DI 19120017577727UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120017577727 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122687 Date10 Jan 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 912001757G0000078AC registered 24 Jul 2026 Active
  • FDA 510(k) K122687 decided 10 Jan 2013 Active
  • FDA GUDID UDI-DI 19120017577727 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122687
  2. Listed FDA GUDID 19120017577727
  3. Registered EUDAMED 912001757G0000078AC

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  • Withdrawn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
SAFETY Blood Collection Set + Blood Culture Holder 23G x 3/4" tubing length 12" (30 cm), single-packed, sterile EUDAMED
Vacuette GUDID
Generic name
Blood collection set, invasive
Device name
SAFETY Blood Collection Sets + Blood Culture Holder
Model / Ref / Catalog
450185, SAFETY Blood Collection Sets + Blood Culture Holder
Primary DI / UDI-DI
19120017577727
Basic UDI-DI
912001757G0000078AC
510(k) Number
FDA product code
JKA
EMDN code
A01010201 Butterfly needles, with safety systems
GMDN term
Blood collection set, invasive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
862.1675
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 set, invasive

Cleared under the same submission (K122687)

Similar devices in this category

Other devices filed under BUTTERFLY NEEDLES, 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)