EUDAMED device

Dexcom ONE+ CGM System

EUDAMED device 00386270003720 · Dexcom

Key facts

Primary DI 00386270003720
Trade name Dexcom ONE+ CGM System
Device name Dexcom ONE+ CGM System
Reference or catalog number STE-D7-001
Manufacturer Dexcom
Manufacturer SRN US-MF-000010694
Risk class Class IIb
EMDN code Z1204011501
EMDN description NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
Status date Jun 3, 2024

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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