Skip to content

Vacuette 450128

by Greiner Bio - One GmbH

Part of a family of 11 devices: see the family page

Ref 450128Model VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set

Vacuette 450128 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 16 Jul 2026 (Basic UDI-DI 912001757G0000082A3), cleared under FDA 510(k) K173757 on 19 Apr 2018 and listed in FDA GUDID since 3 Oct 2019 (UDI-DI 19120049206619), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173757

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912001757G0000082A3 Basic UDI-DI 19120049206619UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120049206619 UDI-DI Date3 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173757 Date19 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 912001757G0000082A3 registered 16 Jul 2026 Active
  • FDA 510(k) K173757 decided 19 Apr 2018 Active
  • FDA GUDID UDI-DI 19120049206619 listed 3 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173757
  2. Listed FDA GUDID 19120049206619
  3. Registered EUDAMED 912001757G0000082A3

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  • Withdrawn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® EVOPROTECT SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 12" (30 cm) EUDAMED
Vacuette GUDID
Generic name
Basic intravenous administration set, invasive
Device name
VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set
Model / Ref / Catalog
450128, VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set
Primary DI / UDI-DI
19120049206619
Basic UDI-DI
912001757G0000082A3
510(k) Number
FDA product code
FMI
EMDN code
A01010201 Butterfly needles, with safety systems
GMDN term
Basic intravenous administration set, invasive
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: Basic intravenous administration set, invasive

Cleared under the same submission (K173757)

and 1 more cleared under K173757

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)