HomeKorea, RepublicRF Medical Co., Ltd.

RF Medical Co., Ltd.

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

This company has registrations in United States, Brazil, Taiwan, Australia, 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
5listed device types
Class I 2Class II 3Class III 0
plus 7 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
8 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIb 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
2active registrations
Class 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 States7 registration records, 4 510(k), 0 PMA, 12 excluded
Brazil6 confirmed, 0 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: RF MEDICAL CO., LTD · RF MEDICAL CO., LTD. · RF MEDICAL Co., Ltd

Company information

Country
Korea, Republic
City
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

12018 · K180999
12020 · K193355
12022 · K221277
12023 · K232763

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Electrosurgical 1Biopsy Needle Guide Kit 1Orthopedic Manual Surgical Instrument 1Dilator, Cervical, Fixed Size 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232763Electrode Handpieces (VCT, RFTV, BMDT series)2023-10-04
USK221277Mygen M-3004 RF Generator M-30042022-09-02
USK193355Electrodes Handpieces for Mygen V-1000 RF System2020-08-03
BR80410909010V-GuideClass II
BR80410900052Kit Cânulas VPClass II
BR80410900054Introdutores Canulados A para cânulas de biópsiaClass II

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