FDA Device Entity Profile: DEXCOM, INC.

Known Identifiers & Locations

FEI Numbers 3004753838, 3013435121, 3027503105, 3037326582

Owner Operator Numbers 9071756

Locations Covered Athenry Galway, IE; Bandar Cassia Pulau Pinang, MY; Mesa, AZ, US; SAN DIEGO, CA, US

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004753838	DEXCOM, INC.	SAN DIEGO, CA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details
3013435121	Dexcom, Inc.	Mesa, AZ, US	Manufacture Device in the United States for Export Only	View Details
3027503105	Dexcom (Malaysia) Sdn. Bhd.	Bandar Cassia Pulau Pinang, MY	Manufacture Medical Device	View Details
3037326582	DEXCOM INTERNATIONAL LIMITED	Athenry Galway, IE	Export Device to the United States But Perform No Other Operation on Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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