Skip to content

Serazym® Clostridium difficile Toxin A+B

by Seramun Diagnostica GmbH

Ref E-040

Active European Union

CE IVDD

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/IVDD NumberB-04099466104038 Basic UDI-DI 04099466104038UDI-DIDate29 Jun 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
E-040
Primary DI / UDI-DI
04099466104038
Basic UDI-DI
B-04099466104038
EMDN Code
W0105011802 C.difficile toxin a/b detection
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000026029

Other devices from Seramun Diagnostica GmbH

See all devices from Seramun Diagnostica GmbH →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

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