Home›USA›Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc.

USA · Madison

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

20listed device types

Class I 5Class II 14Class III 1

plus 102 registration records and 109 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

7 including historic records

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

28active device licences

Class II 6Class III 22

73 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

25device registrations

CLASS B 1CLASS C 24

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

24active ARTG entries

Class I 6IIa 3IIb 14Class Im (measuring) 1

HKHong KongMDACS

15valid listings

Class II 2Class III 13

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

19active registrations

Class 2a 4Class 2b 15

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.

Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States102 registration records, 109 510(k), 1 PMA, 3 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada28 confirmed, 0 excluded

Manufacturer names merged into this page: Datex-Ohmeda, Inc. · DATEX-OHMEDA, INC. · OHMEDA MEDICAL, A DIVISION OF DATEX OHMEDA INC. · DATEX-OHMEDA · DATEX OHMEDA INC · DATEX-OHMEDA INC.

Same-named companies — This database also contains companies with near-identical names: Datex-Ohmeda Inc., A Division of Instrumentarium C, Datex-Ohmeda, Inc., A General Electric Company, Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

122003

102004

102005

32006

22007

32008

12009

32010

32011

22012

32013

42015

22016

22017

12018

12021

22022

22023

12025

22026

FDA listed device types

showing 8 of 20

Uterine Electromyographic Monitor 1Apparatus, Gas-Scavenging 1Cable, Electrode 1Vaporizer, Anesthesia, Non-Heated 1Electrode, Electrocardiograph 1Incubator, Neonatal 1Gas-Machine, Anesthesia 1Ventilator, Emergency, Manual (Resuscitator) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254036	Novii+ Wireless Patch System	2026-08-10
US	K260326	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	2026-07-28
US	K251663	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	2025-10-22
BR	80071260263	SISTEMA DE FOTOTERAPIA LED	Class II
CA	61140	O2 FLOWMETER	Class II
CA	70622	IVENT201 VENTILATOR	Class III
CA	70747	THE IVENT PATIENT BREATHING CIRCUITS	Class II