Identity
- Trade Name
- Dexcom ONE+ CGM System EUDAMED
- Device Name
- Dexcom ONE+ CGM System EUDAMED
- Model / Reference
- STP-D7-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270003775 EUDAMED
- Basic UDI-DI
- 038627D1+CGMKB EUDAMED
- Direct Marketing DI
- 00386270003775 EUDAMED
- EMDN Code
- Z1204011501 NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 ONE+ 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 | 038627D1+CGMKB | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED 49d79980-9800-43cb-9cd7-8ef6d496f593 61 fields · synced Jun 18, 2026