HomeKorea, RepublicSAESHIN PRECISION CO., LTD.

SAESHIN PRECISION CO., LTD.

Korea, Republic · Daegu
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Australia, Israel, Russia — 5 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
15listed device types
Class I 13Class II 2Class III 0
plus 24 registration records and 18 510(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
TWTaiwanTFDA
5valid device licences
Class I 4Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
10active registrations
Class 2a 9Class 2b 1
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 States24 registration records, 18 510(k), 0 PMA
Manufacturer names merged into this page: SAESHIN PRECISION CO., LTD.

Company information

Country
Korea, Republic
City
Daegu

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

22009
12010
12011
12012
32015
12018
22019
12020
12021
12022
12023
22024
12026

FDA listed device types

showing 8 of 15
Motor, Surgical Instrument, Ac-Powered 1Handpiece, Water-Powered 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Controller, Foot, Handpiece And Cord 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Air-Powered, Dental 1Handpiece, Direct Drive, Ac-Powered 1Blade, Saw, Surgical, Cardiovascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251407Motor Handpiece and Control Unit (SDI10)2026-01-30
USK233153Traus SSG10 Surgical System2024-09-20
USK232938Traus SSG30 Surgical System2024-09-16

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