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Contour® Plus Elite

by Ascensia Diabetes Care Holdings AG Switzerland EUDAMED

Ref 90009063Model CPE-M-XXXXYY

EMDN W0201060102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 785593 Date24 Aug 2026IssuedStatusWithdrawn Not intended for the EU market expires 2 Sep 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 785593 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    24 Aug 2026
    Expires
    2 Sep 2029
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Contour Plus Elite Blood Glucose Meter
Model / Reference
CPE-M-XXXXYY, 90009063
Primary DI / UDI-DI
05016003789014
Basic UDI-DI
15016003CPEMB4D
Direct Marketing DI
65016003789016
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C

Manufacturer details

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

Other devices from Ascensia Diabetes Care Holdings AG

See all devices from Ascensia Diabetes Care Holdings AG →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f2d188ce-e92a-4de6-b585-7fa7c012387f 61 fields · synced 24 Oct 2026