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Vidas® 99735

by Biomerieux SA

Ref 99735

Vidas® 99735 is a device classified as IVD General (EU), Class II (US) made by Biomerieux SA, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-03573026140427), cleared under FDA 510(k) K891385 on 18 Apr 1989 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03573026140427), active as of 12 Nov 2026.

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

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K891385

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03573026140427 Basic UDI-DI 03573026140427UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026140427 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK891385 Date18 Apr 1989DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03573026140427 registered 9 Sep 2026 Active
  • FDA 510(k) K891385 decided 18 Apr 1989 Active
  • FDA GUDID UDI-DI 03573026140427 listed 14 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K891385
  2. Listed FDA GUDID 03573026140427
  3. Registered EUDAMED B-03573026140427

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Vidas®
Generic name
Fluorescent immunoassay analyser IVD, laboratory
Model / reference
99735
Primary DI / UDI-DI
03573026140427
Basic UDI-DI
B-03573026140427
510(k) Number
FDA product code
DEW
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Fluorescent immunoassay analyser IVD, laboratory
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.5510
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Fluorescent immunoassay analyser IVD, laboratory

Cleared under the same submission (K891385)

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)