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Insulet Corporation

USA · Acton

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

10listed device types

Class I 2Class II 8Class III 0

plus 13 registration records and 25 510(k)

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

1active device licences

Class III 1

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2Class III 1IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States13 registration records, 25 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Insulet Corporation · INSULET CORPORATION

Business registration

Legal name: INSULET CORP
CIK: 0001145197
Registration status: Active
Listing status: Listed (PODD)

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

12003

12005

12011

12012

12013

12014

12016

12017

12018

32019

12021

52022

32023

22024

12025

12026

FDA listed device types

showing 8 of 10

Introducer, Syringe Needle 1Pump, Infusion, Insulin 1Continuous Glucose Monitor Informed Insulin Dose Calculator 1Alternate Controller Enabled Insulin Infusion Pump 1Injector, Pen 1Calculator, Drug Dose 1System, Test, Blood Glucose, Over The Counter 1Interoperable Automated Glycemic Controller 1

Market	Identifier	Name	Class / date
US	K261461	Omnipod 6 algorithm	2026-06-29
US	K251779	Omnipod 5 algorithm	2025-12-03
US	K241777	SmartAdjust Technology	2024-08-26
CA	89073	LUTREPULSE SYSTEM	Class III

Insulet Corporation

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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