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52 device results listed.

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Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005106
Basic UDI-DI: 038627D1+CGMKB
Reference: STP-D7-001
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Sweden
Authorised representative: MDSS GmbH
Last updated: 18.10.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005090
Basic UDI-DI: 038627D1+CGMKB
Reference: STP-D7-004
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Croatia
Authorised representative: MDSS GmbH
Last updated: 18.10.2026 16:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005083
Basic UDI-DI: 038627D1+CGMKB
Reference: STP-D7-003
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Bulgaria
Authorised representative: MDSS GmbH
Last updated: 18.10.2026 11:09

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Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005069
Basic UDI-DI: 038627D1+CGMKB
Reference: STE-D7-004
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Romania
Authorised representative: MDSS GmbH
Last updated: 18.10.2026 07:11

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Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005052
Basic UDI-DI: 038627D1+CGMKB
Reference: STE-D7-003
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Bulgaria
Authorised representative: MDSS GmbH
Last updated: 18.10.2026 02:46

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005045
Basic UDI-DI: 038627D1+CGMKB
Reference: STE-D7-002
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 17.10.2026 22:37

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Dexcom ONE+ CGM System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring functionSingle useSterile

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005038
Basic UDI-DI: 038627D1+CGMKB
Reference: STE-D7-001
EMDN: Z1204011585
EMDN description: INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 17.10.2026 19:05

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Dexcom ONE+ CGM System

Class IIbNot specifiedOn the market

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270005120
Basic UDI-DI: 038627D1+CGMKB
Reference: STP-D7-002
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 14.10.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom Clarity

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000491
Basic UDI-DI: 038627CLARITY48
Reference: 350-0011
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:26

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Dexcom Clarity

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000705
Basic UDI-DI: 038627CLARITY48
Reference: 350-0013
EMDN: Z1204011501
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:26

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Dexcom Clarity

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000699
Basic UDI-DI: 038627CLARITY48
Reference: 350-0021
EMDN: Z1204011501
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Dexcom API

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Dexcom
Manufacturer SRN: US-MF-000010694
UDI-DI: 00386270000668
Basic UDI-DI: 038627APIUC
Reference: SW13183
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 15.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details