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Clostridium Difficile CM0601B

by Oxoid Limited

Ref CM0601B

Clostridium Difficile CM0601B is a device classified as IVD General (EU), Class I (US) made by Oxoid Limited, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI B-05032384003648), cleared under FDA 510(k) K802495 on 18 Dec 1980 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 05032384003648), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K802495

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05032384003648 Basic UDI-DI 05032384003648UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384003648 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK802495 Date18 Dec 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05032384003648 registered 24 Aug 2026 Active
  • FDA 510(k) K802495 decided 18 Dec 1980 Active
  • FDA GUDID UDI-DI 05032384003648 listed 7 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K802495
  2. Listed FDA GUDID 05032384003648
  3. Registered EUDAMED B-05032384003648

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  • Withdrawn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
Clostridium Difficile
Generic name
Differential/selective agar culture medium IVD
Model / reference
CM0601B
Primary DI / UDI-DI
05032384003648
Basic UDI-DI
B-05032384003648
510(k) Number
FDA product code
JSJ
EMDN code
W0104010101 Dehydrated culture media (dcm)
GMDN term
Differential/selective agar culture medium IVD
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.2360
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 I

Device class is stated on each registry's own scale: Class IVD General 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: Differential/selective agar culture medium IVD

Similar devices in this category

Other devices filed under DEHYDRATED CULTURE MEDIA (DCM).

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 (19, all answered No)