HomeKorea, RepublicWON TECH CO. LTD

WON TECH CO. LTD

Korea, Republic · Daejeon
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 32 registration records and 30 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
6 including historic records
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
19valid device licences
Class II 19
SGSingaporeHSA SMDR
6device registrations
CLASS C 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
16active ARTG entries
Class I 2IIa 3IIb 11
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 1Class 2b 2
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 States32 registration records, 30 510(k), 0 PMA
Brazil1 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: WONTECH Co., Ltd. · WONTECH CO., LTD. · WON TECH CO. LTD

Company information

Country
Korea, Republic
City
Daejeon

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

12017
22018
42019
22020
32022
32023
72024
82025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Powered Laser Surgical Instrument 1Laser, Comb, Hair 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252877SANDRO Dual2025-12-19
USK250165Pastelle2025-07-03
USK251288Veincare2025-05-14
BR81118639009Hair Boom AirClass II

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