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CT1964B

by Oxoid Limited

Ref CT1964B

CT1964B 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-05032384526116), cleared under FDA 510(k) K203700 on 30 Jul 2021 and listed in FDA GUDID since 7 Dec 2021 (UDI-DI 05032384526116), 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) K203700

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-05032384526116 Basic UDI-DI 05032384526116UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384526116 UDI-DI Date7 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203700 Date30 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032384526116 registered 24 Aug 2026 Active
  • FDA 510(k) K203700 decided 30 Jul 2021 Active
  • FDA GUDID UDI-DI 05032384526116 listed 7 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203700
  2. Listed FDA GUDID 05032384526116
  3. Registered EUDAMED B-05032384526116

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  • Withdrawn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
Cefidericol
Generic name
Antibacterial susceptibility testing disc IVD
Model / reference
CT1964B
Primary DI / UDI-DI
05032384526116
Basic UDI-DI
B-05032384526116
510(k) Number
FDA product code
JTN
EMDN code
W0104080502 Impregnated disks, multi-disks & tablets
GMDN term
Antibacterial 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: Antibacterial 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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)