Identity
- Trade Name
- Dexcom Flex CGM System EUDAMED
- Device Name
- Dexcom Flex Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- STE-DF-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270005281 EUDAMED
- Basic UDI-DI
- 038627DEXFLEX67 EUDAMED
- Direct Marketing DI
- 00386270004581 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dexcom Flex CGM System by Dexcom — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038627DEXFLEX67 | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED a1b4e52e-444e-4a75-9dba-fbfdf35bab00 61 fields · synced Jul 18, 2026