HomeKorea, RepublicGni Co., Ltd.

Gni Co., Ltd.

Korea, Republic · Hwaseong-Si
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Russia — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
21listed device types
Class I 18Class II 3Class III 0
plus 22 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
1 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2a 3Class 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 States22 registration records, 3 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: GNI Co., LTD · GNI CO., LTD

Company information

Country
Korea, Republic
City
Hwaseong-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

12019 · K182672
12020 · K191041
12021 · K201410

FDA listed device types

showing 8 of 21
Spring, Orthodontic 1Pusher, Band, Orthodontic 1Aligner, Bracket, Orthodontic 1Maintainer, Space Preformed, Orthodontic 1Band, Preformed, Orthodontic 1Clamp, Wire, Orthodontic 1Tube, Orthodontic 1Instrument, Ligature Tucking, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201410VENUS Bracket, ROSE Bracket2021-03-12
USK191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]2020-08-28
USK182672ROSA Bracket2019-11-15
BR82502810001Instrumentais Ortho Mini Screw ToolClass I
BR80853390009BRÁQUETES ORTODÔNTICOS ESTÉTICOSClass II

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