HomeChinaStryker (Suzhou) Medical Technology Co.,Ltd.

Stryker (Suzhou) Medical Technology Co.,Ltd.

China · Suzhou Jiangsu
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
46listed device types
Class I 18Class II 28Class III 0
plus 49 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
30registered devices
Class I 29Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
26registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
13active device licences
Class II 13
26 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States49 registration records, 14 510(k), 0 PMA, 77 excluded
Brazil30 confirmed, 21 excluded
Saudi Arabia26 confirmed, 9 excluded
Canada13 confirmed, 15 excluded
Manufacturer names merged into this page: STRYKER MEDICAL · Stryker (Suzhou) Medical Technology Co.,Ltd. · STRYKER (SUZHOU) MEDICAL TECHNOLOGY CO., LTD · Stryker (Suzhou) Medical Technology Co. Ltd · Stryker Medical

Company information

Country
China
City
Suzhou Jiangsu

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

11991
21992
51994
11995
12011
12016
12017
12018
12023

FDA listed device types

showing 8 of 46
Stretcher, Hand-Carried 1Cushion, Flotation 1Board, Cardiopulmonary 1Monitor, Bed Patient 1Protector, Skin Pressure 1Stand, Infusion 1Chair, Examination And Treatment 1Cover, Mattress (Medical Purposes) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222818Xpedition ™ Powered Stair Chair (625700000000)2023-01-24
USK180834Altrix Precision Temperature Management System2018-08-10
USK171149Altrix Temperature Management Wraps2017-07-18
BR80005439001MACA HOSPITALAR STRYKERClass I
BR80005430588MACA PERFORMANCE-PRO XT STRYKERClass I
BR80005430393MACAS PARA TRANSPORTE PRIME MANUAISClass I
SAME0000000992SFDAA00184fFoam Mattress
SAME0000001368SFDAA00002Foam Mattress
CA60667MEDI-TEMPClass II
CA60709BLOOD/FLUID WARMER SETClass II
CA60818THERMACARE QUILTClass II

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