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Ohmeda Medical

USA · Tampa
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Russia — 4 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
124510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 124 510(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
4active device licences
Class II 4
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 States0 registration records, 124 510(k), 0 PMA, 8 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada4 confirmed, 2 excluded
Manufacturer names merged into this page: OHMEDA MEDICAL, A DIVISION OF DATEX OHMEDA INC.
Same-named companies — This database also contains companies with near-identical names: Datex Division Instrumentarium Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Tampa

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

61991
51992
41993
71994
21995
51996
31997
41998
11999
22000
32001
22002
12004
42007
12009
32010
12012
12013
12015
12016

Registration details (sample)

MarketIdentifierNameClass / date
USK152814Giraffe OmniBed Carestation CS12016-03-17
USK152809Giraffe Incubator Carestation CS12015-12-31
USK123309GIRAFFE AND PANDA WARMERS2013-02-05
CA8476VACUUM REGULATORSClass II
CA8494PEDIACTRIC AEROSOL TENTClass II
CA8497INTERMITTENT SUCTION UNITClass II

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