FDA.reportPublic FDA data

DEXCOM INTERNATIONAL LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30373265823037326582DEXCOM INTERNATIONAL LIMITED1N2026-01-01Newford Athenry Galway IE H65 F978

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3471441745741017K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2025-04-09
3471441885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
3471441519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBJ22025-04-09
SAF12024-03-05