Identity
- Trade Name
- Dexcom Flex CGM System EUDAMED
- Device Name
- Dexcom Flex Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- STK-DF-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270005328 EUDAMED
- Basic UDI-DI
- 038627DEXFLEX67 EUDAMED
- Direct Marketing DI
- 00386270005304 EUDAMED
- EMDN Code
- Z1204011502 INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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 ceb8ba85-816b-4b9e-b8fb-111a117f1583 61 fields · synced Jul 8, 2026