HomeKorea, RepublicClassys, Inc.

Classys, Inc.

Korea, Republic · Seoul
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel, Russia — 7 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
9listed device types
Class I 1Class II 8Class III 0
plus 16 registration records and 4 510(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
0active device licences
10 including historic records
TWTaiwanTFDA
8valid device licences
Class II 8
SGSingaporeHSA SMDR
5device registrations
CLASS B 1CLASS C 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
15active ARTG entries
Class I 2IIa 3IIb 10
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 2Class 2b 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 States16 registration records, 4 510(k), 0 PMA
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: CLASSYS INC · CLASSYS INC.

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

12023 · K230100
12024 · K240248
12025 · K253123
12026 · K253504

FDA listed device types

showing 8 of 9
Electrosurgical, Cutting & Coagulation & Accessories 1Skin Resurfacing Rf Applicator 1Camera, Ophthalmic, Ac-Powered 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Electrosurgical Coagulation For Aesthetic 1Massager, Vacuum, Radio Frequency Induced Heat 1Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253504Volnewmer™2026-07-13
USK253123CuRAS hybrid2025-11-20
USK240248Volnewmer™2024-04-29

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