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BK MEditec Co., Ltd

Korea, Republic

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

26listed device types

Class I 18Class II 8Class III 0

plus 31 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 5Class II 1

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States31 registration records, 11 510(k), 0 PMA, 7 excluded

Brazil6 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BK MEDITECH CO., LTD. · BK MEDITECH · BK MEDITECK CO. LTD. · BK MEditec Co., Ltd · BK MEDITECK Co, Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200981	Mega Plus MIS Spine System	2020-08-11
US	K183080	Mega Plus Spine System	2018-12-10
US	K173180	Mega Plus Spine System	2018-03-15
BR	80454380016	FIXADORES EXTERNOS PARA MEMBROS SUPERIORES - BK MEDITECH	Class I
BR	80454380020	FAMÍLIA DE FIXADORES EXTERNOS PARA MEMBROS INFERIORES - BK	Class I
BR	80454380011	INSTRUMENTOS CIRÚRGICOS ARTICULADOS NÃO CORTANTES - BK MEDITECH	Class I

BK MEditec 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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