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Dexcom Flex CGM System

by Dexcom United States EUDAMED

Ref STK-DF-109

EMDN Z1204011502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038627DEXFLEX67 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Dexcom Flex Continuous Glucose Monitoring System
Model / Reference
STK-DF-109
Primary DI / UDI-DI
00386270005335
Basic UDI-DI
038627DEXFLEX67
Direct Marketing DI
00386270005311
EMDN Code
Z1204011502 Invasive blood sugar monitoring systems
Device Class
Class IIb
Market of Registration
Germany

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 b92795d0-6ba0-43bf-b7b1-c24d07c13346 61 fields · synced 22 Oct 2026