Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037326582

FEI Number

3037326582

Entity Name

DEXCOM INTERNATIONAL LIMITED

City/State/Country

Athenry Galway, IE

Establishment Address

Newford, Athenry Galway H65 F978, IE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DEXCOM, INC. (Owner Number: 9071756)

Owner / Operator Contact Address

6340 Sequence Drive, --, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K234070

PMA Number

N/A

All Registered Proprietary Names

DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM Dexcom G7 Continuous Glucose Monitoring System Stelo Glucose Biosensor System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-08-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-08-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-11-25
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-11-25
SAF	Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter	Clinical Chemistry	Class 2	862.1355	2024-03-19

Official Correspondent

Avi Brown

US Agent Details

Avi Brown Business: DEXCOM, INC. Email: fda.oc@dexcom.com Phone: (858) 2817153

Related Public Records

Same Entity

DEXCOM, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027503105	Dexcom (Malaysia) Sdn. Bhd.	Bandar Cassia Pulau Pinang, MY
3013435121	Dexcom, Inc.	Mesa, AZ, US
3004753838	DEXCOM, INC.	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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2024024	Sterigenics Radiation Technologies, LLC	San Diego, CA, US
3004105270	PLEXUS CORP.	BUFFALO GROVE, IL, US
3003600763	Flextronics Manufacturing Aguascalientes, S.A de C.V	Aguascalientes, MX
9710492	ABBOTT DIABETES CARE LIMITED	WITNEY OXON Oxfordshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037326582. Last updated year: 2026. Please use registration number 3037326582 when referencing this establishment in official correspondence.