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HAMILTON MEDICAL, INC.

Switzerland · Bonaduz

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 37 registration records and 45 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 4Class III 4

26 including historic records

TWTaiwanTFDA

11valid device licences

Class I 1Class II 10

SGSingaporeHSA SMDR

7device registrations

CLASS B 2CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

20active ARTG entries

Class I 3Class III 6IIa 4IIb 7

HKHong KongMDACS

10valid listings

Class II 1Class III 9

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 1Class 2b 6

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 States37 registration records, 45 510(k), 0 PMA, 12 excluded

Brazil0 confirmed, 6 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: HAMILTON MEDICAL AG · Hamilton Medical AG · HAMILTON MEDICAL, INC.

FDA 510(k) clearances by year

11996

21999

12000

22003

12004

12005

22006

22007

22008

12009

12010

22011

52012

22013

12015

32016

22017

12019

22020

12021

FDA listed device types

showing 8 of 9

Set, Tubing And Support, Ventilator (W Harness) 1Tubing, Pressure And Accessories 1Mixer, Breathing Gases, Anesthesia Inhalation 1Cuff, Tracheal Tube, Inflatable 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer 1Ventilator, Continuous, Facility Use 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201306	HAMILTON-C3	2021-02-05
US	K201658	Hamilton-C6	2020-12-11
US	K193228	Hamilton-G5	2020-05-04
CA	37918	ARABELLA	Class II
CA	62629	RAPHAEL	Class III
CA	68680	GALILEO GOLD VENTILATOR SYSTEM	Class III