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Geenius 92465

by Bio-Rad

Ref 92465

Geenius 92465 is a device classified as Class A in the EU and Class I in the US made by Bio-Rad, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 361052A001607S) and listed in FDA GUDID since 3 Feb 2023 (UDI-DI 03610520010785), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A001607S Basic UDI-DI 03610520010785UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610520010785 UDI-DI Date3 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361052A001607S registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 03610520010785 listed 3 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03610520010785
  2. Registered EUDAMED 361052A001607S

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  • Withdrawn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
Geenius Reader EUDAMED
Geenius GUDID
Generic name
Photometric/spectroscopic immunoassay analyser IVD
Device name
Cassette Reader
Model / Ref / Catalog
92465
Primary DI / UDI-DI
03610520010785
Basic UDI-DI
361052A001607S
FDA product code
LXG
EMDN code
W0204 Infectious immunology instruments
GMDN term
Photometric/spectroscopic immunoassay analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Photometric/spectroscopic immunoassay analyser IVD

Similar devices in this category

Other devices filed under INFECTIOUS IMMUNOLOGY INSTRUMENTS.

Other devices from Bio-Rad

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Properties

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