HomeTaiwanGEMORE TECHNOLOGY CO., LTD.

GEMORE TECHNOLOGY CO., LTD.

Taiwan · Taipei
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 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
12listed device types
Class I 3Class II 9Class III 0
plus 20 registration records and 14 510(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
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States20 registration records, 14 510(k), 0 PMA
Manufacturer names merged into this page: GEMORE TECHNOLOGY CO., LTD.

Company information

Country
Taiwan
City
Taipei

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

32003
12004
12006
12007
12009
22011
32012
12015
12019

FDA listed device types

showing 8 of 12
Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Pad, Heating, Powered 1Stimulator, Muscle, Powered 1Media, Electroconductive 1Electrode, Cutaneous 1Interferential Current Therapy 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1

Registration details (sample)

MarketIdentifierNameClass / date
USK190988GIM-STIM OTC TENS/EMS System2019-08-16
USK150681GEMORE OTC TENS2015-05-12
USK122948GEM-STIM COMBO STIMULATOR2012-12-21

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