HomeChinaTouchstone International Medical Science Co.,Ltd.

Touchstone International Medical Science Co.,Ltd.

China · Suzhou · www.touchstone.hk
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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
0UDI-DI device records
USUnited StatesFDA openFDA
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class IIa 3Class IIb 5
BRBrazilANVISA
3registered devices
Class II 3
14 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
3device registrations
CLASS B 1CLASS C 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
9active ARTG entries
Class I 1IIa 2IIb 6
HKHong KongMDACS
14valid listings
Class II 5Class III 9
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
15active registrations
Class 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.

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 States5 registration records, 2 510(k), 0 PMA
United Kingdom8 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. · TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO. LTD. · TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD

Regulatory identity

UK responsible person
SHARE INFO LTD

Company information

Country
China
City
Suzhou
Website
www.touchstone.hk
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

22014 · K141097

FDA listed device types

Staple, Implantable 1Stapler, Surgical 1Clamp, Penile 1Staple, Removable (Skin) 1Apparatus, Suturing, Stomach And Intestinal 1

Registration details (sample)

MarketIdentifierNameClass / date
UK63228Circumcision Stapler for Single UseClass IIa
UK59871Endoscopic Linear Cutter and Single Use Loading UnitClass IIb
UK58483Powered Universal HandleClass IIa
USK141097CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE2014-09-26
USK141367LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS2014-07-25
BR80136999107TSN - Grampeador AutomáticoClass II
BR80136990937Pinça Descartável Automática para Sutura em BolsaClass II
BR80136990932Dispositivo Descartável para CircuncisãoClass II

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