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Dexcom ONE+ CGM System

by Dexcom United States EUDAMED

Ref SW14245

EMDN Z12040292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038627D1+CGMKB Basic UDI-DIDate31 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SW14245
Primary DI / UDI-DI
00386270004314
Basic UDI-DI
038627D1+CGMKB
Direct Marketing DI
00386270004314
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000010694
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Dexcom

See all devices from Dexcom →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8a1a2a6e-983a-4890-8266-82749dd20764 61 fields · synced 24 Oct 2026