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Vitek 10.0

by Biomerieux, Inc.

Ref 423737

Vitek 10.0 is a device classified as Class B in the EU and Class II in the US made by Biomerieux, Inc., registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 357302BUDI002135TG), cleared under FDA 510(k) K234012 on 14 Mar 2025 and listed under FDA premarket submission N50510 on 1 Aug 1979 and in 1 more registry, active as of 24 Oct 2026.

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

CE IVDR PMA 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) K234012

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI002135TG Basic UDI-DI 03573026618285UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026618285 UDI-DI Date15 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK234012 Date14 Mar 2025DecidedStatusActive
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberN50510 Date1 Aug 1979DecidedStatusActive

Official records

Across registries

4 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI002135TG registered 1 Oct 2026 Active
  • FDA 510(k) K234012 decided 14 Mar 2025 Active
  • FDA premarket submission N50510 decided 1 Aug 1979 Active
  • FDA GUDID UDI-DI 03573026618285 listed 15 May 2025 Listed

Timeline

4 dated events

  1. Decided FDA premarket submission N50510
  2. Cleared FDA 510(k) K234012
  3. Listed FDA GUDID 03573026618285
  4. Registered EUDAMED 357302BUDI002135TG

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vitek
Generic name
Microorganism identification/antimicrobial-susceptibility analyser IVD
Model / reference
423737 EUDAMED
10.0 GUDID
Primary DI / UDI-DI
03573026618285
Basic UDI-DI
357302BUDI002135TG
FDA product code
LON
EMDN code
W0203010182 Antibiotic susceptibility analysers - software accessories
GMDN term
Microorganism identification/antimicrobial-susceptibility analyser IVD
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.1645
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
423737
GUDID
10.0
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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: Microorganism identification/antimicrobial-susceptibility analyser IVD

Cleared under the same submission (K234012)

Cleared under the same submission (N50510)

and 8 more cleared under N50510

Similar devices in this category

Other devices filed under ANTIBIOTIC SUSCEPTIBILITY ANALYSERS.

Other devices from Biomerieux, Inc.

See all devices from Biomerieux, Inc. →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
Other properties (23, all answered No)