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Vacuette 450040

by Greiner Bio - One GmbH

Ref 450040Model VACUETTE® VISIO PLUS Needles

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912001757G0000076A8 Basic UDI-DI 19120017570056UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number19120017570056 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
VACUETTE® VISIO PLUS Needle 21G x 1 1/2" green, sterile, not made with natural rubber latex 0.8 x 38 mm EUDAMED
Vacuette GUDID
Generic Name
Non-fixed blood collection needle
Device Name
VACUETTE® VISIO PLUS Needles
Model / Ref / Catalog
450040, VACUETTE® VISIO PLUS Needles
Primary DI / UDI-DI
19120017570056 EUDAMED
29120017570053 GUDID
Basic UDI-DI
912001757G0000076A8
510(k) Number
FDA Product Code
FMI
EMDN Code
A01010502 Needles for collection under vacuum, w/o safety systems
GMDN Term
Non-fixed blood collection needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5570
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
19120017570056
GUDID
29120017570053
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K061483)

Other devices from Greiner Bio - One GmbH

See all devices from Greiner Bio - One GmbH →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No