HomeKorea, RepublicAMT ENGINEERING CO., LTD.

AMT ENGINEERING CO., LTD.

Korea, Republic · Seongnam-Si Gyeonggi
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia — 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
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 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
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 States4 registration records, 2 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: AMT ENGINEERING CO., LTD. · AMT Engineering Co., Ltd.

Company information

Country
Korea, Republic
City
Seongnam-Si Gyeonggi

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

12023 · K230340
12024 · K241672

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Powered Laser Surgical Instrument 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241672COPRO 32024-09-06
USK230340Lucas Plus2023-05-04
SAME0000002642SFDAA00002Botosonic Plus

Similar companies

A-ZoneTech Co., LTD
Korea, Republic · markets 0
AB Medical, Inc.
Korea, Republic · markets 8
Ace Medical Co., Ltd
Korea, Republic · markets 9
AIT Studio Co., Ltd.
Korea, Republic · markets 1
AITRICS CO.,LTD
Korea, Republic · markets 2
Allmedicus Co., Ltd.
Korea, Republic · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →