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Home›Brazil›VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA.

VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA.

Brazil · Sao Paulo
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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
4listed device types
Class I 0Class II 4Class III 0
plus 8 registration records and 6 510(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
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States8 registration records, 6 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Vydence Medical Industria e Comercio Ltda · VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA · VYDENCE MEDICAL - INDUSTRIA E COMERCIO LTDA.
Same-named companies — This database also contains companies with near-identical names: Vydence Medical. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil
City
Sao Paulo

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 · K171443
12019 · K190007
12021 · K202998
12022 · K220041
12024 · K242534
12026 · K252753

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252753Vydence Family of Lasers2026-01-24
USK242534HandPICO Fractional Laser Handpiece Tip2024-12-20
USK220041HandPICO2022-05-05
BR80058589010Sistema a LED para TerapiaClass II
BR80058589006Aparelho eletromédico de radiofrequência fracionado por microagulhamenClass II
BR80058589003APARELHO ELETROMÉDICO DE TERAPIA POR RESFRIAMENTO DO ARClass II

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