← Back to catalogue
Dexcom ONE Continuous Glucose Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref STP-DO-002Model STP-DO-002/ Dexcom ONE Starter Kit - Greece/Romania mg/dLRef STS-DO-001Model STS-DO-001/ Dexcom ONE Sensor 1-packRef STT-DO-001Model STT-DO-001/ Dexcom ONE TransmitterRef STP-DO-003Model STP-DO-003/ Dexcom ONE Starter Kit - Belgium/France mg/dLRef STP-DO-109Model STP-DO-109/ Dexcom One Starter Kit - Croatia mmol/LRef STS-DO-003Model STS-DO-003/ Dexcom ONE Sensor 3-packRef STP-DO-005Model STP-DO-005/ Dexcom ONE Starter Kit - Spain 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
- STP-DO-002/ Dexcom ONE Starter Kit - Greece/Romania mg/dL EUDAMEDSTP-DO-002 EUDAMEDSTS-DO-001/ Dexcom ONE Sensor 1-pack EUDAMEDSTS-DO-001 EUDAMEDSTT-DO-001/ Dexcom ONE Transmitter EUDAMEDSTT-DO-001 EUDAMEDSTP-DO-003/ Dexcom ONE Starter Kit - Belgium/France mg/dL EUDAMEDSTP-DO-003 EUDAMEDSTP-DO-109/ Dexcom One Starter Kit - Croatia mmol/L EUDAMEDSTP-DO-109 EUDAMEDSTS-DO-003/ Dexcom ONE Sensor 3-pack EUDAMEDSTS-DO-003 EUDAMEDSTP-DO-005/ Dexcom ONE Starter Kit - Spain mg/dL EUDAMEDSTP-DO-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270002778 EUDAMED00386270001825 EUDAMED00386270002785 EUDAMED00386270000651 EUDAMED00386270002761 EUDAMED00386270001832 EUDAMED00386270002297 EUDAMED
- Basic UDI-DI
- B-00386270002778 EUDAMEDB-00386270001825 EUDAMEDB-00386270002785 EUDAMEDB-00386270000651 EUDAMEDB-00386270002761 EUDAMEDB-00386270001832 EUDAMEDB-00386270002297 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMEDBelgium EUDAMEDCroatia EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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-00386270002778 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (7)
- EUDAMED baec38c1-5e21-447d-8767-a41a564eb5d5 61 fields · synced Jul 30, 2026
- EUDAMED 49c912e0-2938-4a82-ac28-3691151becb8 61 fields · synced May 18, 2026
- EUDAMED 12319c45-b213-4e1d-a057-a09789877104 61 fields · synced May 18, 2026
- EUDAMED ddaca4a8-00d1-4e84-9b91-4792bf834490 61 fields · synced May 18, 2026
- EUDAMED e44d59ef-5b79-4d03-9fd0-782287132bf9 61 fields · synced May 18, 2026
- EUDAMED 064c610b-f7ca-4a9f-973e-106f6b73d4b9 61 fields · synced May 18, 2026
- EUDAMED e2a4be14-618d-4693-ae0d-530349238c1f 61 fields · synced May 18, 2026