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Serazym® Clostridium difficile GDH

by Seramun Diagnostica GmbH

Ref E-107

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-04099466110732 Basic UDI-DI 04099466110732UDI-DIDate13 Jul 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  • Withdrawn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-107
Primary DI / UDI-DI
04099466110732
Basic UDI-DI
B-04099466110732
EMDN Code
W0105011801 C.difficile gdh detection
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000026029

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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