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VITEK REVEAL SOFTWARE v1.3 ANALYSIS

by bioMérieux, Inc.

Ref 425332

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03573026646011 UDI-DI Date12 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number357302BUDI002318TS Basic UDI-DI 03573026646011UDI-DIDate30 Jul 2026RegisteredStatusActive

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 22 Oct 2026.

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  • Withdrawn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

Generic Name
Laboratory instrument/analyser application software IVD
Model / Reference
425332 EUDAMED
1.3 GUDID
Primary DI / UDI-DI
03573026646011
Basic UDI-DI
357302BUDI002318TS
510(k) Number
FDA Product Code
LON, SAN
EMDN Code
W02039092 Various microbiology instruments - IVD medical device software
GMDN Term
Laboratory instrument/analyser application software IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
866.1645, 866.1650
Special Device Type
Software
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
425332
GUDID
1.3
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000011802
Authorised representative
bioMérieux SA FR-AR-000004435

Other devices from Biomérieux

See all devices from Biomérieux →

Properties

  • Professional Testing
  • Surgical Instrument
  • New Device
  • Prescription Use

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No