Identity
- Trade Name
- Dexcom Flex CGM System EUDAMED
- Device Name
- Dexcom Flex Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- SW14684 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270005236 EUDAMED
- Basic UDI-DI
- 038627DEXFLEX67 EUDAMED
- Direct Marketing DI
- 00386270005236 EUDAMED
- EMDN Code
- Z12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE 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 e5e44ade-2537-4adc-888e-a959259b0ce9 61 fields · synced Jul 12, 2026