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Dexcom ONE Continuous Glucose Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref STK-DO-013Model STK-DO-013/ Dexcom ONE Receiver Kit (mg/dL)
by Dexcom
Identity
- Trade Name
- Dexcom ONE Continuous Glucose Monitoring System EUDAMED
- Device Name
- Dexcom ONE Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- STK-DO-013/ Dexcom ONE Receiver Kit (mg/dL) EUDAMEDSTK-DO-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270002327 EUDAMED
- Basic UDI-DI
- B-00386270002327 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dexcom ONE Continuous Glucose Monitoring System by Dexcom — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00386270002327 | Class IIb | Active |
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Manufacturer
Sources (1)
- EUDAMED ec28580e-6baa-422f-8eb3-7296e2b44ba3 61 fields · synced Jun 18, 2026