GENOSS Co., Ltd.

Korea, Republic · Suwon-Si

✓ 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

16listed device types

Class I 5Class II 11Class III 0

plus 29 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

17valid device licences

Class II 13Class III 4

SGSingaporeHSA SMDR

12device registrations

CLASS B 7CLASS D 4D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class III 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 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 States29 registration records, 23 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: GENOSS Co., Ltd. · GENOSS CO. LTD. · GENOSS CO.,LTD.

FDA 510(k) clearances by year

12007

12009

12010

12011

12012

22015

62016

12017

32020

12022

12023

32024

12025

FDA listed device types

showing 8 of 16

Bur, Dental 1Handpiece, Direct Drive, Ac-Powered 1Tray, Impression, Preformed 1Accessories, Implant, Dental, Endosseous 1Elevator, Surgical, Dental 1Barrier, Animal Source, Intraoral 1Scaler, Rotary 1Activator, Ultraviolet, For Polymerization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242386	Bluemoon	2025-05-05
US	K222688	The Trust	2024-08-09
US	K233885	rainbow Paste Stain SE	2024-06-21
BR	82696710055	BRIGHT INFLADOR B30/B40 - GENOSS	Class I
BR	82696719020	VALVULA HEMOSTÁTICA COM CONECTOR Y - GENOSS	Class II
BR	82696719021	Cateter-balão PTA - GENOSS	Class II

GENOSS Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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