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Contour® Care

by Ascensia Diabetes Care Holdings AG Switzerland EUDAMED

Ref 90009546Model CCARE-M-XXXXYY

EMDN W0201060102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15016003CCAREMBV4 Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 785595 Supplemented

    Technical documentation EU IVDR

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

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Contour Care Blood Glucose Meter
Model / Reference
CCARE-M-XXXXYY, 90009546
Primary DI / UDI-DI
05016003965210
Basic UDI-DI
15016003CCAREMBV4
Direct Marketing DI
65016003965212
EMDN Code
W0201060102 Blood glucose meters
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
  • 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 7f8a4c4f-f880-466b-9ed2-d72ffcccaa58 61 fields · synced 23 Oct 2026