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Home›USA›JEISYS MEDICAL NORTH AMERICA INC

JEISYS MEDICAL NORTH AMERICA INC

USA · Burlington
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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
Same-named companies — This database also contains companies with near-identical names: Jeisys Medical Incorporated. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Burlington

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

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)

MarketIdentifierNameClass / date
USK251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)2025-10-03
USK250065DENSITY; DENZA; DENSITY Noir2025-07-08
USK231216POTENZA2024-12-10
BR80117580276UNIDADE DE FOTOTERAPIAClass II
BR10343659012ULTRAcel Q+Class II
BR80117589109Sistema estimulador de ultra-som focalizadoClass II
CA84279INTRACEL FRACTIONAL RF MICRO-NEEDLE SYSTEMClass III

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