HomeTaiwanComfort Orthopedic Co., Ltd.

Comfort Orthopedic Co., Ltd.

Taiwan · Hsin-Chu City
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
13510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 13
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
23registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
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, 13 510(k), 0 PMA, 31 excluded
Brazil13 confirmed, 7 excluded
Saudi Arabia23 confirmed, 2 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: COMFORT ORTHOPEDIC CO., LTD. · COMFORT ORTHOPEDIC CO. LTD. · COMFORT ORTHOPEDIC CO. · COMFORT ORTHOPEDIC CO.,LTD. · Comfort Orthopedic Co., Ltd. · Comfort Orthopedic Co,LTD

Company information

Country
Taiwan
City
Hsin-Chu City

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

42002
32003 · K031618
12004 · K031621
22006 · K063030
22007 · K072711
12010 · K102734

Registration details (sample)

MarketIdentifierNameClass / date
USK102734COMFORT STANDING WHEELCHAIR, HERO SERIES2010-12-14
USK072711COMFORT POWERED WHEELCHAIR, LY-EB 2062007-10-31
USK072712COMFORT ELECTRIC SCOOTER, LY-EW4082007-10-31
BR10335109013ANDADOR COM RODASClass I
BR10335109021CADEIRAS DE RODAS COMFORT - AIRCRAFT SERIEClass I
BR10335100017CADEIRA DE RODAS COMFORTClass I
SAME0000008557SFDAA00001COMFORT
SAME0000008557SFDAA00002Comfort

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