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Itamar Medical , Ltd.

Israel · Caesarea

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Israel, Russia — 8 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

4listed device types

Class I 1Class II 3Class III 0

plus 23 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

5active device licences

Class II 4Class III 1

9 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States23 registration records, 20 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: ITAMAR MEDICAL · Itamar Medical Ltd. (Alon) · ITAMAR MEDICAL LTD · ITAMAR MEDICAL LTD.

FDA 510(k) clearances by year

22001

12002

12003

12004

32008

12011

12014

12016

12017

12018

12019

32022

12023

12025

12026

FDA listed device types

Ventilatory Effort Recorder 1Computer, Diagnostic, Programmable 1Powered Laser Surgical Instrument 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254042	WatchPAT SW	2026-07-31
US	K250460	WatchPAT400 (WP400)	2025-09-05
US	K223675	WatchPAT ONE (WP1)	2023-01-06
BR	10178010240	BIO SENSOR ENDOPAT	Class II
BR	10178019039	Watch-PAT300	Class II
CA	38479	WATCH PAT 100	Class III
CA	86745	WATCH-PAT200	Class II
CA	87675	WATCH-PAT TAMPER-PROOF BRACELET	Class II

Itamar Medical , Ltd.

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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