HomeKorea, RepublicMCTBIO CO., LTD

MCTBIO CO., LTD

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

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel, 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
20listed device types
Class I 19Class II 0Class III 0unclassified 1
plus 20 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
22registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
6valid device licences
Class I 4Class II 1Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 2Class 2a 2Class 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 States20 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia22 confirmed, 0 excluded
Manufacturer names merged into this page: MCTBIO · MCTBIO CO., LTD

Company information

Country
Korea, Republic
City
Yongin-Si Gyeonggi

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 listed device types

showing 8 of 20
Forceps 1Chisel, Surgical, Manual 1Accessories, Implant, Dental, Endosseous 1Drill, Dental, Intraoral 1Retainer, Screw Expansion, Orthodontic 1Hammer, Surgical 1Handle, Instrument, Dental 1Scale, Patient 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80724000034KIT TAC MASTERClass I
BR80724000027FAMILIA DE INSTRUMENTOS NÃO ARTICULADOS E CORTANTESClass I
SAME0000012750SFDAA00002Saw Cover Set II
SAME0000012750SFDAA00003Sinus Master Kit III

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