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Ketostix®

by Ascensia Diabetes Care Holdings AG 3 variants

Ref 1885365Model KSTIX-U-XXXXYY

Ketostix® (1885365) is a Class C device made by Ascensia Diabetes Care Holdings AG, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 15016003KSTIXUBG8), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

7 Jul 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15016003KSTIXUBG8 Basic UDI-DI 15016003288705UDI-DIDate22 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 785590 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Ketostix Reagent Strips
Model / reference
KSTIX-U-XXXXYY, 1885365
Primary DI / UDI-DI
15016003288705
Basic UDI-DI
15016003KSTIXUBG8
Unit of use DI
25016003288702
EMDN code
W0101060201 Urine single test strips (incl. tablets)
Device class
Class C
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

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

Similar devices in this category

Other devices filed under URINE TESTING (CC) - RT & POC.

Other devices from Ascensia Diabetes Care Holdings AG

See all devices from Ascensia Diabetes Care Holdings AG →

Properties

  • Self-testing
Other properties (12, all answered No)