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DRAEGER MEDICAL SYSTEMS, INC.

USA · Telford

✓ 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

46listed device types

Class I 5Class II 41Class III 0

plus 41 registration records and 145 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

41active device licences

Class II 11Class III 30

97 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

15device registrations

CLASS B 3CLASS C 12

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

43active ARTG entries

Class I 10IIa 7IIb 26

HKHong KongMDACS

8valid listings

Class II 2Class III 6

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 3Class 2b 8

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 States41 registration records, 145 510(k), 0 PMA, 7 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada41 confirmed, 1 excluded

Manufacturer names merged into this page: DRAEGER MEDICAL SYSTEMS, INC. · DRÄGER MEDICAL SYSTEMS, INC.

FDA 510(k) clearances by year

42003

162004

62005

72006

22007

92008

12009

42010

22011

42012

22013

52014

22015

32018

12020

12021

22022

22023

22024

12025

FDA listed device types

showing 8 of 46

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1Amplifier And Signal Conditioner, Transducer Signal 1Electrode, Electrocardiograph 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Incubator, Neonatal 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243606	Babyroo TN300	2025-01-17
US	K240312	Infinity CentralStation Wide	2024-08-01
US	K233834	Infinity Gateway Suite	2024-07-12
BR	10303949037	Medidor de icterícia JM-105	Class II
CA	3689	CO-WRITER ANESTHESIA RECORDER	Class II
CA	3695	OXYMED OXYGEN MONITOR	Class III
CA	3699	DRAGER AV-E ANESTHESIA VENTILATOR	Class III