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CT0059B

by Oxoid Limited

Ref CT0059B

CT0059B is a device classified as IVD General (EU), Class II (US) made by Oxoid Limited, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI B-05032384006045), cleared under FDA 510(k) K971637 on 23 Dec 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05032384006045), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K971637

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05032384006045 Basic UDI-DI 05032384006045UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384006045 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK971637 Date23 Dec 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032384006045 registered 24 Aug 2026 Active
  • FDA 510(k) K971637 decided 23 Dec 1997 Active
  • FDA GUDID UDI-DI 05032384006045 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K971637
  2. Listed FDA GUDID 05032384006045
  3. Registered EUDAMED B-05032384006045

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  • Withdrawn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
Compound Sulphonamides
Generic name
Sulphonamide compound susceptibility testing disc IVD
Model / reference
CT0059B
Primary DI / UDI-DI
05032384006045
Basic UDI-DI
B-05032384006045
510(k) Number
FDA product code
JTN
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
GMDN term
Sulphonamide compound 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: Sulphonamide compound susceptibility testing disc IVD

Similar devices in this category

Other devices filed under IMPREGNATED DISKS, MULTI-DISKS & TABLETS.

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)