HomeTaiwanZmi Electronics , Ltd.

Zmi Electronics , Ltd.

Taiwan · Kaohsiung
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, 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
14listed device types
Class I 1Class II 13Class III 0
plus 20 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
14 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 4IIa 1
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 States20 registration records, 4 510(k), 0 PMA, 2 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: ZMI ELECTRONICS LTD. · ZMI ELECTRONICS LTD · ZMI Electronics Ltd

Company information

Country
Taiwan
City
Kaohsiung

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

12018 · K180865
12022 · K220997
12024 · K231166
12025 · K241862

FDA listed device types

showing 8 of 14
Lamp, Infrared, Therapeutic Heating 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Stimulator, Neuromuscular, External Functional 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Light Based Over The Counter Wrinkle Reduction 1Electrode, Cutaneous 1Stimulator, Muscle, Powered, For Muscle Conditioning 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241862Levina Pelvic Floor Muscle Stimulator (RS-48)2025-03-27
USK231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes2024-01-18
USK220997Wireless TENS/EMS, Bruno, Aela2022-09-01
SAME0000005267SFDAA00005Cellulose Sponge
SAME0000005268SFDAA00001Future Cure Self-adhesive Electrodes
CA74744NEUROPROBE 500Class II
CA74924PROBE APPLICATORS FOR NEUROPROBE 500Class II
CA75877OMNISTIM STIMULATORClass II

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