Skip to content

Dexcom Flex CGM System

by Dexcom 6 variants

Ref STE-DF-001

Dexcom Flex CGM System (STE-DF-001) is a Class IIb device made by Dexcom, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 038627DEXFLEX67), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038627DEXFLEX67 Basic UDI-DI 00386270005281UDI-DIDate13 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Dexcom Flex Continuous Glucose Monitoring System
Model / reference
STE-DF-001
Primary DI / UDI-DI
00386270005281
Basic UDI-DI
038627DEXFLEX67
Direct marketing DI
00386270004581
EMDN code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device class
Class IIb
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS.

Other devices from Dexcom

See all devices from Dexcom →

Properties

  • Supplied sterile
  • Sterilise before use
  • Measuring function
Other properties (11, all answered No)