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Dexcom ONE+ CGM System
EUDAMEDClass IIb (EU MDR)
Ref STE-D7-002Ref STK-D7-013Ref STP-D7-002Ref STP-D7-003Ref STE-D7-001Ref STE-D7-003Ref STP-D7-001Ref SW10930Ref SW14255Ref SW14256Ref SW14245Ref SW14361Ref SW10846Ref SW10847Ref SW14244Ref STP-D7-006
by Dexcom
Identity
- Trade Name
- Dexcom ONE+ CGM System EUDAMED
- Device Name
- Dexcom ONE+ CGM System EUDAMED
- Model / Reference
- STE-D7-002 EUDAMEDSTK-D7-013 EUDAMEDSTP-D7-002 EUDAMEDSTP-D7-003 EUDAMEDSTE-D7-001 EUDAMEDSTE-D7-003 EUDAMEDSTP-D7-001 EUDAMEDSW10930 EUDAMEDSW14255 EUDAMEDSW14256 EUDAMEDSW14245 EUDAMEDSW14361 EUDAMEDSW10846 EUDAMEDSW10847 EUDAMEDSW14244 EUDAMEDSTP-D7-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00386270003744 EUDAMED00386270003812 EUDAMED00386270003737 EUDAMED00386270003751 EUDAMED00386270003720 EUDAMED00386270003768 EUDAMED00386270003713 EUDAMED00386270001573 EUDAMED00386270004482 EUDAMED00386270004475 EUDAMED00386270004314 EUDAMED00386270004826 EUDAMED00386270001542 EUDAMED00386270001559 EUDAMED00386270004307 EUDAMED00386270005076 EUDAMED
- Basic UDI-DI
- 038627D1+CGMKB EUDAMED
- Direct Marketing DI
- 00386270003744 EUDAMED00386270003812 EUDAMED00386270003737 EUDAMED00386270003751 EUDAMED00386270003720 EUDAMED00386270003768 EUDAMED00386270003713 EUDAMED00386270001573 EUDAMED00386270004482 EUDAMED00386270004475 EUDAMED00386270004314 EUDAMED00386270004826 EUDAMED00386270001542 EUDAMED00386270001559 EUDAMED00386270004307 EUDAMED00386270004888 EUDAMED
- EMDN Code
- Z1204011501 NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS EUDAMEDZ12040292 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDZ1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMEDItaly EUDAMEDNetherlands EUDAMEDBulgaria EUDAMEDIreland EUDAMEDSpain EUDAMEDGermany EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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 (16)
- EUDAMED f89d943b-7748-4084-a63e-7012e6b17337 61 fields · synced Jul 29, 2026
- EUDAMED 0201dca6-3848-4117-af0b-0d0f551202c1 61 fields · synced May 16, 2026
- EUDAMED 65d07c81-1f4b-4608-a333-3c2562aec1a4 61 fields · synced May 17, 2026
- EUDAMED f31377b9-ce78-420a-9d59-26fd24fbc27c 61 fields · synced May 17, 2026
- EUDAMED a6e36de6-c499-47c7-8f49-d5def1065952 61 fields · synced May 18, 2026
- EUDAMED fb13dcde-c043-41a6-bc02-91887f4122fc 61 fields · synced May 18, 2026
- EUDAMED c3f041f0-cd2d-425c-b37a-a3de4fb66b6c 61 fields · synced May 18, 2026
- EUDAMED 2883919a-027b-4ba6-befe-ce0ccb890997 61 fields · synced Jul 9, 2026
- EUDAMED 2232fbdd-0e16-4c5b-83ef-649df22e57f5 61 fields · synced Jul 10, 2026
- EUDAMED 53802b9c-485e-4281-b01b-d3d535366abe 61 fields · synced Jul 12, 2026
- EUDAMED 8a1a2a6e-983a-4890-8266-82749dd20764 61 fields · synced Jul 14, 2026
- EUDAMED f2884932-03d1-43db-8d03-9c8866fb3084 61 fields · synced Jul 17, 2026
- EUDAMED f390c43e-e524-4a4f-99cc-d58b7597fc45 61 fields · synced Jul 21, 2026
- EUDAMED e65e210d-4283-446e-81b0-43873987008e 61 fields · synced Jul 22, 2026
- EUDAMED 500422f6-87c0-4fc5-a177-274e141b8474 61 fields · synced Jul 26, 2026
- EUDAMED 8af355b6-5a88-4ff8-882d-13df0ddde3ee 61 fields · synced Jul 29, 2026