HomeKorea, RepublicBISON MÉDICAL CO., LTD.

BISON MÉDICAL CO., LTD.

Korea, Republic · Geumcheon Gu Seoul
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, 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
2listed device types
Class I 0Class II 2Class III 0
plus 6 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class 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
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 1Class 2b 2
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 States6 registration records, 3 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: BISON MEDICAL CO., LTD · BISON MÉDICAL CO., LTD.

Company information

Country
Korea, Republic
City
Geumcheon Gu Seoul

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

12015 · K150997
22016 · K161670

FDA listed device types

Powered Laser Surgical Instrument 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

MarketIdentifierNameClass / date
USK161670Lucid Q-PTP / HWA 552016-11-02
USK160227ACCENTO / HWA Dual/Single laser2016-04-22
USK150997RUBY STAR2015-12-22
BR82869199001ELADERMClass II

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