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CT0794B

by Oxoid Limited

Ref CT0794B

CT0794B is a device classified as IVD General (EU), Class II (US) made by Oxoid Limited, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI B-05032384007011), cleared under FDA 510(k) K984608 on 9 Mar 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05032384007011), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K984608

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/IVDD EUDAMED NumberB-05032384007011 Basic UDI-DI 05032384007011UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384007011 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK984608 Date9 Mar 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032384007011 registered 26 Aug 2026 Active
  • FDA 510(k) K984608 decided 9 Mar 1999 Active
  • FDA GUDID UDI-DI 05032384007011 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K984608
  2. Listed FDA GUDID 05032384007011
  3. Registered EUDAMED B-05032384007011

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  • Withdrawn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
Gentamicin
Generic name
Gentamicin susceptibility testing disc IVD
Model / reference
CT0794B
Primary DI / UDI-DI
05032384007011
Basic UDI-DI
B-05032384007011
510(k) Number
FDA product code
JTN
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
GMDN term
Gentamicin susceptibility testing disc IVD
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.1620
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
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: Gentamicin susceptibility testing disc IVD

Similar devices in this category

Other devices filed under MANUAL SUSCEPTIBILITY TESTING.

Other devices from Oxoid Limited

See all devices from Oxoid Limited →

Properties

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