HomeKorea, RepublicNuga Medical Co., Ltd.

Nuga Medical Co., Ltd.

Korea, Republic · Wonju City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 4 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
6listed device types
Class I 1Class II 4Class III 0unclassified 1
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
1active device licences
Class II 1
TWTaiwanTFDA
5valid device licences
Class I 1Class II 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2a 4
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 States4 registration records, 3 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: NUGA MEDICAL CO LTD · NUGA MEDICAL CO., LTD.

Company information

Country
Korea, Republic
City
Wonju City

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

12011 · K111329
12016 · K153054
12024 · K240168

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Table, Physical Therapy, Multi Function 1Pad, Heating, Powered 1Massager, Powered Inflatable Tube 1Massager, Therapeutic, Electric 1Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240168N7-S2024-09-12
USK153054N5-12016-02-05
USK111329NM-70002011-09-06
CA88162PERSONAL HEATING THERAPEUTIC DEVICE NM-7000Class II

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