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Leadgene® Indoxyl Sulfate (IS) ELISA Kit

by Leadgene Biomedical, Inc.

Ref LGM-18002

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04719893060027 Basic UDI-DI 04719893060027UDI-DIDate12 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-04719893060027 Basic UDI-DI 04719893060027UDI-DIDate12 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
LGM-18002
Primary DI / UDI-DI
04719893060027
Basic UDI-DI
B-04719893060027, 471989306LGM18002T9
EMDN Code
W01010299 Substrates - other
Device Class
Class IVD General
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000037178
Authorised representative
mdi Europa GmbH DE-AR-000006218

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No