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iRhythm Technologies, Inc.

USA · Cypress

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

7listed device types

Class I 2Class II 5Class III 0

plus 19 registration records and 18 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States19 registration records, 18 510(k), 0 PMA

Manufacturer names merged into this page: iRhythm Technologies, Inc. · IRHYTHM TECHNOLOGIES, INC.

FDA 510(k) clearances by year

12008

22009

22012

12014

12015

12017

12018

12019

22021

12022

12023

22024

12025

12026

FDA listed device types

Detector And Alarm, Arrhythmia 1Transmitters And Receivers, Electrocardiograph, Telephone 1Outpatient Cardiac Telemetry 1Computer, Diagnostic, Programmable 1Recorder, Magnetic Tape, Medical 1Degreaser, Skin, Surgical 1Razor, Surgical 1

Market	Identifier	Name	Class / date
US	K252859	ZEUS Platform (FG0501US)	2026-05-29
US	K243650	Zio® monitor (DFG0001)	2025-08-15
US	K240177	Zio AT® device (A100A1001)	2024-10-30

iRhythm Technologies, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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