Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

17.07.2026 13:39

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Successful

Device

2837375

Actor

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Certificate

3107

Active filter:Manufacturer SRN:US-MF-000010694

44 device results listed.

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00386270005342

CGM Informed Therapy Adjustment

Class IIbMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270005342
Basic UDI-DI
038627DEXBASAL64
Reference
SW14553
EMDN
Z12040292
EMDN description
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Germany
Authorised representative
MDSS GmbH
Last updated
15.07.2026 23:45
Dexcom Flex CGM System

Dexcom Flex Continuous Glucose Monitoring System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270004598
Basic UDI-DI
038627DEXFLEX67
Reference
STP-DF-001
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Germany
Authorised representative
MDSS GmbH
Last updated
15.07.2026 23:45
Dexcom ONE+ CGM System

Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001542
Basic UDI-DI
038627D1+CGMKB
Reference
SW10846
EMDN
Z12040292
EMDN description
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
Germany
Authorised representative
MDSS GmbH
Last updated
15.07.2026 23:45
Dexcom ONE Continuous Glucose Monitoring System

STK-DO-109/ Dexcom ONE Receiver Kit (mmol/L)

Class IIbMDDOn the marketActive deviceMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002792
Basic UDI-DI
B-00386270002792
Reference
STK-DO-109
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Bulgaria
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STT-DO-001/ Dexcom ONE Transmitter

Class IIbMDDOn the marketActive deviceMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002785
Basic UDI-DI
B-00386270002785
Reference
STT-DO-001
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Belgium
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-002/ Dexcom ONE Starter Kit - Greece/Romania mg/dL

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002778
Basic UDI-DI
B-00386270002778
Reference
STP-DO-002
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Greece
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-109/ Dexcom One Starter Kit - Croatia mmol/L

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002761
Basic UDI-DI
B-00386270002761
Reference
STP-DO-109
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Croatia
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-101/ Dexcom ONE Starter Kit - Estonia/Latvia/Lithuania mmol/L

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002747
Basic UDI-DI
B-00386270002747
Reference
STP-DO-101
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Estonia
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STK-DO-013/ Dexcom ONE Receiver Kit (mg/dL)

Class IIbMDDOn the marketActive deviceMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002327
Basic UDI-DI
B-00386270002327
Reference
STK-DO-013
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Belgium
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-005/ Dexcom ONE Starter Kit - Spain mg/dL

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270002297
Basic UDI-DI
B-00386270002297
Reference
STP-DO-005
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Spain
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-102/ mmol/L, Dexcom ONE Starter Kit, Bulgaria

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001849
Basic UDI-DI
B-00386270001849
Reference
STP-DO-102
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Netherlands
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STS-DO-003/ Dexcom ONE Sensor 3-pack

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001832
Basic UDI-DI
B-00386270001832
Reference
STS-DO-003
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Belgium
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STS-DO-001/ Dexcom ONE Sensor 1-pack

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001825
Basic UDI-DI
B-00386270001825
Reference
STS-DO-001
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Belgium
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Dexcom ONE Continuous Glucose Monitoring System

STP-DO-003/ Dexcom ONE Starter Kit - Belgium/France mg/dL

Class IIbMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270000651
Basic UDI-DI
B-00386270000651
Reference
STP-DO-003
EMDN
Z1204011585
EMDN description
INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country
Belgium
Authorised representative
MDSS GmbH
Last updated
04.07.2026 16:50
Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001559
Basic UDI-DI
038627D1+CGMKB
Reference
SW10847
EMDN
Z12040292
EMDN description
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
-
Authorised representative
MDSS GmbH
Last updated
22.06.2026 18:05
Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function
Manufacturer
Dexcom
Manufacturer SRN
US-MF-000010694
UDI-DI
00386270001566
Basic UDI-DI
038627D1+CGMKB
Reference
SW10920
EMDN
Z12040292
EMDN description
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country
-
Authorised representative
MDSS GmbH
Last updated
22.06.2026 18:05