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CHROMagar™ C.difficile base

by CHROMagar™ 2 variants

Ref CD122(B)

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376034476CD12B2G Basic UDI-DI 03760344760400UDI-DIDate20 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
CD122(B)
Primary DI / UDI-DI
03760344760400
Basic UDI-DI
376034476CD12B2G
EMDN Code
W0104010101 Dehydrated culture media (dcm)
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000024723

From the manufacturer

Manufacturer's product page: CHROMagar™ C.difficile Pour la détection de Clostridioides difficile

Other devices from CHROMagar™

See all devices from CHROMagar™ →

Properties

  • Animal Tissues
  • Microbial Substances

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No