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Dynex Dsx 65100

by Dynex Technologies Inc

Part of a family of 6 devices: see the family page

Ref 65100Model DSX

Dynex Dsx 65100 is a device classified as Class A in the EU and Class I in the US made by Dynex Technologies Inc, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 506045618DSXFQ) and listed in FDA GUDID since 7 Feb 2022 (UDI-DI 05060456180287), 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 Number506045618DSXFQ Basic UDI-DI 05060456180287UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060456180287 UDI-DI Date7 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506045618DSXFQ registered 26 May 2026 Active
  • FDA GUDID UDI-DI 05060456180287 listed 7 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060456180287
  2. Registered EUDAMED 506045618DSXFQ

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  • Withdrawn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
DSX Automated ELISA System - Ambient EUDAMED
Dynex Dsx GUDID
Generic name
Multiple clinical chemistry analyser IVD, laboratory
Device name
DSX Automated ELISA System
Model / Ref / Catalog
65100, DSX
Primary DI / UDI-DI
05060456180287
Basic UDI-DI
506045618DSXFQ
FDA product code
LXG, JJQ, JQW
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Multiple clinical chemistry analyser IVD, laboratory
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2050, 862.2300, 862.2750
EU registration type
Standard device
EU market of registration
Spain
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: Multiple clinical chemistry analyser IVD, laboratory

Similar devices in this category

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

Other devices from Dynex Technologies Inc

See all devices from Dynex Technologies Inc →

Properties

  • Professional testing
  • IVD instrument
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)