HomeKorea, RepublicShinhung Company, Ltd.

Shinhung Company, Ltd.

Korea, Republic · Ansan-Si
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel, Russia — 7 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
6listed device types
Class I 6Class II 0Class III 0
plus 7 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
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 3IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States7 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: SHINHUNG CO. LTD. · SHINHUNG CO., LTD.

Company information

Country
Korea, Republic
City
Ansan-Si

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

12016 · K151996
12023 · K213749

FDA listed device types

Accessory, Surgical Apparel 1Clamp, Rubber Dam 1Unit, Operative Dental 1Needle, Dental 1Crown, Preformed 1Chair, Dental, Without Operative Unit 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213749G7, Dental Operative Unit and Accessories2023-04-03
USK151996TAURUS C12016-01-22

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