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Jeisys Medical Incorporated

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

8listed device types

Class I 1Class II 7Class III 0

plus 32 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

11 including historic records

TWTaiwanTFDA

14valid device licences

Class II 14

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 5IIa 3IIb 10

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 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 States32 registration records, 18 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: JEISYS MEDICAL NORTH AMERICA INC · JEISYS MEDICAL INC. · JEISYS MEDICAL · JEISYS MEDICAL INC

FDA 510(k) clearances by year

22008

12010

22015

22016

12019

22020

12021

12022

22023

22024

22025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Skin Resurfacing Rf Applicator 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption 1Powered Laser Surgical Instrument 1Motor, Surgical Instrument, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251464	TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)	2025-10-03
US	K250065	DENSITY; DENZA; DENSITY Noir	2025-07-08
US	K231216	POTENZA	2024-12-10
BR	80117580276	UNIDADE DE FOTOTERAPIA	Class II
BR	10343659012	ULTRAcel Q+	Class II
BR	80117589109	Sistema estimulador de ultra-som focalizado	Class II
CA	84279	INTRACEL FRACTIONAL RF MICRO-NEEDLE SYSTEM	Class III

Jeisys Medical Incorporated

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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