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Keto-Diastix

by Ascensia Diabetes Care Holdings AG Switzerland EUDAMED

Ref 5019794Model KDSTIX-U-XXXXYY

EMDN W0101060201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15016003KDSTIXUBKZ Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 785591 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Keto-Diastix Reagent Strips
Model / Reference
KDSTIX-U-XXXXYY, 5019794
Primary DI / UDI-DI
15016003288309
Basic UDI-DI
15016003KDSTIXUBKZ
Unit of Use DI
25016003288306
EMDN Code
W0101060201 Urine single test strips (incl. tablets)
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000034124
Authorised representative
Ascensia Diabetes Care Italy Srl IT-AR-000025584

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 15016003288309|15016003KDSTIXUBKZ 61 fields · synced 24 Oct 2026