Manufacturer

Dexcom

United States

First countries of placing on the market declared in EUDAMED : Belgium, Bulgaria, Croatia, Czechia, Estonia, Germany, Greece, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden

Public contracts won : Italy 1

EU representative : MDSS GmbH (Germany)

Website

4 categories, 17 models including 17 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Invasive blood sugar monitoring systems, single-use sensors	Z1204011585	Dexcom Flex CGM System3 refs Dexcom ONE Continuous Glucose Monitoring System STK-DO-013/ Dexcom ONE Receiver Kit (mg/dL)93/42 Dexcom ONE Continuous Glucose Monitoring System STK-DO-109/ Dexcom ONE Receiver Kit (mmol/L)93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-002/ Dexcom ONE Starter Kit - Greece/Romania mg/dL93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-003/ Dexcom ONE Starter Kit - Belgium/France mg/dL93/42 7 others Dexcom ONE Continuous Glucose Monitoring System STP-DO-005/ Dexcom ONE Starter Kit - Spain mg/dL93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-101/ Dexcom ONE Starter Kit - Estonia/Latvia/Lithuania mmol/L93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-102/ mmol/L, Dexcom ONE Starter Kit, Bulgaria93/42 Dexcom ONE Continuous Glucose Monitoring System STP-DO-109/ Dexcom One Starter Kit - Croatia mmol/L93/42 Dexcom ONE Continuous Glucose Monitoring System STS-DO-001/ Dexcom ONE Sensor 1-pack93/42 Dexcom ONE Continuous Glucose Monitoring System STS-DO-003/ Dexcom ONE Sensor 3-pack93/42 Dexcom ONE Continuous Glucose Monitoring System STT-DO-001/ Dexcom ONE Transmitter93/42	IIb MDR, 93/42	EUDAMED record Report an error
Blood sugar monitoring systems - other	Z1204011599	Dexcom API Dexcom Follow App3 refs	I, IIb MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - medical device software	Z12040292	CGM Informed Therapy Adjustment Dexcom ONE+ CGM System3 refs	IIb MDR	EUDAMED record Report an error
Non invasive blood sugar monitoring systems	Z1204011501	Dexcom Clarity3 refs	I MDR	EUDAMED record Report an error

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