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X & V Factor DD0005T

by Oxoid Limited

Ref DD0005T

X & V Factor DD0005T is a device classified as Class B in the EU and Class I in the US made by Oxoid Limited, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 5032384X&VFactorQY), cleared under FDA 510(k) K802502 on 12 Nov 1980 and listed in FDA GUDID since 4 Dec 2022 (UDI-DI 05032384034109), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K802502

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5032384X&VFactorQY Basic UDI-DI 05032384034109UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384034109 UDI-DI Date4 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK802502 Date12 Nov 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5032384X&VFactorQY registered 20 Aug 2026 Active
  • FDA 510(k) K802502 decided 12 Nov 1980 Active
  • FDA GUDID UDI-DI 05032384034109 listed 4 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K802502
  2. Listed FDA GUDID 05032384034109
  3. Registered EUDAMED 5032384X&VFactorQY

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
X & V Factor
Generic name
X/V factor differentiation disc IVD
Model / reference
DD0005T
Primary DI / UDI-DI
05032384034109
Basic UDI-DI
5032384X&VFactorQY
510(k) Number
FDA product code
JTO
EMDN code
W0104080208 Single tests (discs, strips, droppers...)
GMDN term
X/V factor differentiation disc IVD
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.2660
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: X/V factor differentiation disc IVD

Cleared under the same submission (K802502)

Similar devices in this category

Other devices filed under SINGLE TESTS (DISCS, STRIPS, DROPPERS...).

Other devices from Oxoid Limited

See all devices from Oxoid Limited →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)