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Vitek®ms Vitek Ms

by Biomerieux SA

Ref 543106

Vitek®ms Vitek Ms is a device classified as Class A in the EU and Class II in the US made by Biomerieux SA, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 357302BUDI002043TA) and listed in FDA GUDID since 8 Mar 2024 (UDI-DI 03573026626211), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI002043TA Basic UDI-DI 03573026626211UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026626211 UDI-DI Date8 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI002043TA registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 03573026626211 listed 8 Mar 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 03573026626211
  2. Registered EUDAMED 357302BUDI002043TA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vitek® Ms Smartcalibrant EUDAMED
Vitek®ms GUDID
Generic name
Mass spectrometry analyser calibration kit IVD
Model / reference
543106 EUDAMED
VITEK MS GUDID
Primary DI / UDI-DI
03573026626211
Basic UDI-DI
357302BUDI002043TA
FDA product code
QBN
EMDN code
W01040601 Qc strains bacteriology
GMDN term
Mass spectrometry analyser calibration kit IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
866.3378
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
543106
GUDID
VITEK MS
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A 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: Mass spectrometry analyser calibration kit IVD

Similar devices in this category

Other devices filed under MICROBIOLOGY (CULTURE).

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Properties

  • Single use
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)