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Leadgene® Indoxyl Sulfate (IS) ELISA Kit

by Leadgene Biomedical, Inc.

Ref LGM-18002-01Model LGM-18002

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 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 Number471989306LGM18002T9 Basic UDI-DI 04719893060072UDI-DIDate14 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
LGM-18002, LGM-18002-01
Primary DI / UDI-DI
04719893060072
Basic UDI-DI
471989306LGM18002T9
EMDN Code
W01010299 Substrates - other
Device Class
Class B

Manufacturer details

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

Other devices from Leadgene Biomedical, Inc.

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