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Dexcom ONE+ CGM System

by Dexcom United States EUDAMED

Ref STP-D7-002

EMDN Z1204011501

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
STP-D7-002
Primary DI / UDI-DI
00386270003737, 00386270005120
Basic UDI-DI
038627D1+CGMKB
Direct Marketing DI
00386270003737
00386270004888
EMDN Code
Z1204011501, Z1204011585
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Measuring Function
Other properties (11)
  • 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 (2)

  • EUDAMED 65d07c81-1f4b-4608-a333-3c2562aec1a4 61 fields · synced 24 Oct 2026
  • EUDAMED 00386270005120|038627D1+CGMKB 61 fields · synced 24 Oct 2026