EUDAMED update: Apr 6, 2026

Dexcom

US-MF-000010694

Active44 devices

Address: Sequence Dr, 6340 92121 San Diego
Role: Manufacturer
Date of registration: Jul 28, 2021
Country: United States

Dexcom is a medical device manufacturer registered in EUDAMED. The company has 44 devices on the EU market across 32 countries. Headquartered in San Diego, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Dexcom

: US-MF-000010694
Role: Manufacturer
Country: United States
Organization name: Dexcom
EU VAT number: Not applicable
Date of registration: Jul 28, 2021

Contact details for Dexcom

Phone: 1-888-738-3646
Email: ukie.sales@dexcom.com
Website: www.dexcom.com
Address: 6340, SEQUENCE DR 92121 SAN DIEGO UNITED STATES

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Competent authority

Name: DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover

Phone: -
Email: poststelle@gaa-h.niedersachsen.de

Officers and regulatory representatives of Dexcom

CEVASCO Lisa
Mesa Manufacturing Site: The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Hidden
PETERSON Tim
Corporate Quality Compliance: The reporting obligations referred to in Articles 87 to 91 are fulfilled, specifically Field Safety Corrective Actions, and reporting unacceptable trends per Article 88
Hidden
SHARMA Neeta
Corporate Regulatory Affairs: The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Hidden
MCBEAN Nicole
San Diego Manufacturing Site: The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Hidden
NG Gen Yi
Malaysia Manufacturing Site: The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Hidden
CANTU Robert
Corporate Quality: The post-market surveillance obligations are complied with in accordance with Article 10(10). The reporting obligations referred to in Articles 87 to 91 are fulfilled.

Connected operators

Importers

3 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Dexcom API	Dexcom API	`SW13183`	`00386270000668`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0021`	`00386270000699`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0011`	`00386270000491`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0013`	`00386270000705`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STK-DF-109`	`00386270005335`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STE-DF-001`	`00386270005281`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STK-DF-013`	`00386270005328`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STP-DF-001`	`00386270004598`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`SW14682`	`00386270005212`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`SW14684`	`00386270005236`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-005`	`00386270002297`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STS-DO-001`	`00386270001825`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-101`	`00386270002747`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STT-DO-001`	`00386270002785`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STK-DO-109`	`00386270002792`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-109`	`00386270002761`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-002`	`00386270002778`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-003`	`00386270000651`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STK-DO-013`	`00386270002327`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STS-DO-003`	`00386270001832`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-102`	`00386270001849`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`SW14245`	`00386270004314`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STP-D7-004`	`00386270003775`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STP-D7-001`	`00386270003713`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STK-D7-103`	`00386270003836`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Dexcom API	Dexcom API	`SW13183`	`00386270000668`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0021`	`00386270000699`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0011`	`00386270000491`	1	On the market
Dexcom Clarity	Dexcom Clarity	`350-0013`	`00386270000705`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STK-DF-109`	`00386270005335`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STE-DF-001`	`00386270005281`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STK-DF-013`	`00386270005328`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`STP-DF-001`	`00386270004598`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`SW14682`	`00386270005212`	1	On the market
Dexcom Flex CGM System	Dexcom Flex CGM System	`SW14684`	`00386270005236`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-005`	`00386270002297`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STS-DO-001`	`00386270001825`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-101`	`00386270002747`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STT-DO-001`	`00386270002785`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STK-DO-109`	`00386270002792`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-109`	`00386270002761`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-002`	`00386270002778`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-003`	`00386270000651`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STK-DO-013`	`00386270002327`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STS-DO-003`	`00386270001832`	1	On the market
Dexcom ONE Continuous Glucose Monitoring System	Dexcom ONE Continuous Glucose Monitoring System	`STP-DO-102`	`00386270001849`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`SW14245`	`00386270004314`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STP-D7-004`	`00386270003775`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STP-D7-001`	`00386270003713`	1	On the market
Dexcom ONE+ CGM System	Dexcom ONE+ CGM System	`STK-D7-103`	`00386270003836`	1	On the market

Dexcom

About Dexcom

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Competent authority

Officers and regulatory representatives of Dexcom

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About Dexcom

Contact details for Dexcom

Export the 44 devices of Dexcom

Competent authority

Officers and regulatory representatives of Dexcom

Statistics for Dexcom

Certificate health for Dexcom

Devices by risk class

Market presence of Dexcom

Device catalog for Dexcom

Device families (Basic UDI-DI) of Dexcom

Connected operators

Importers

Related searches

Certificate health for Dexcom

Statistics for Dexcom

Market presence of Dexcom

Devices by risk class

Device families (Basic UDI-DI) of Dexcom

Device catalog for Dexcom