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OSUNG MND CO., LTD.

Korea, Republic · Gimpo-Si Gyeonggi

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia — 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

67listed device types

Class I 66Class II 1Class III 0

plus 67 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

12registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

23active ARTG entries

Class I 23

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 States67 registration records, 1 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: OSUNG MND CO., LTD. · OSUNG MND CO.LTD. · Osung Mnd Co., Ltd

FDA 510(k) clearances by year

12015 · K141854

FDA listed device types

showing 8 of 67

Knife, Margin Finishing, Operative 1Pusher, Band, Orthodontic 1Curette, Periodontic 1Frame, Rubber Dam 1Carrier, Amalgam, Operative 1Evacuator, Oral Cavity 1Scissors, Surgical Tissue, Dental 1Unit, Suction Operatory 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141854	INSTRUMENT CASSETTE (EFCCL1-F)	2015-10-29
BR	80601260010	TIRA DE LIXA PARA DESGASTE INTERPROXIMAL	Class I
SA	ME0000022164SFDAA00002	Luxating Elevator	—
SA	ME0000022164SFDAA00013	Rubber Dam Plier	—

OSUNG MND 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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