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Vitros 1922814

by Ortho-Clinical Diagnostics

Ref 6801059Model VITROS

Vitros 1922814 is a device classified as Class A in the EU and Class I in the US made by Ortho-Clinical Diagnostics, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 10758750000272K7) and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 10758750000272), active as of 7 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number10758750000272K7 Basic UDI-DI 10758750000272UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10758750000272 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 10758750000272K7 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 10758750000272 listed 31 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10758750000272
  2. Registered EUDAMED 10758750000272K7

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  • Withdrawn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
Vitros Eci Immunodiagnostic System EUDAMED
Vitros GUDID
Generic name
Chemiluminescent immunoassay analyser IVD
Device name
VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished
Model / Ref / Catalog
VITROS EUDAMED
6801059 EUDAMED
1922814 GUDID
Primary DI / UDI-DI
10758750000272
Basic UDI-DI
10758750000272K7
FDA product code
KHO
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Chemiluminescent immunoassay analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2560
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
VITROS
6801059
GUDID
1922814
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Chemiluminescent immunoassay analyser IVD

Similar devices in this category

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

Other devices from Ortho-Clinical Diagnostics

See all devices from Ortho-Clinical Diagnostics →

Properties

  • Reagent
  • Professional testing
  • IVD instrument
  • Prescription use
  • Combination product
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)