HomeUSADEXCOM, INC.

DEXCOM, INC.

USA · San Diego
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
9listed device types
Class I 2Class II 7Class III 0
plus 18 registration records and 28 510(k), 134 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
9registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 28 510(k), 134 PMA, 2 excluded
Manufacturer names merged into this page: DEXCOM, INC. · Dexcom, Inc.

Company information

Country
USA
City
San Diego

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
DEXCOM INC
CIK
0001093557
Registration status
Active
Listing status
Listed (DXCM)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12014
12015
32018
42019
22020
22021
22022
22023
32024
32025
52026

FDA listed device types

showing 8 of 9
Continuous Glucose Monitor Secondary Display 1Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter 1Integrated Continuous Glucose Monitoring System, Factory Calibrated 1Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use 1Continuous Glucose Monitor Informed Insulin Dose Calculator 1Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management 1Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter 1Continuous Glucose Monitor Retrospective Data Analysis Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK262472Stelo Glucose Biosensor System2026-08-11
USK260935Stelo Glucose Biosensor System2026-06-12
USK261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System2026-06-08

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