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Home›Brazil›A. R. INDÚSTRIA E COMÉRCIO DE INSTRUMENTOS CIRÚRGICOS LTDA - ME

A. R. INDÚSTRIA E COMÉRCIO DE INSTRUMENTOS CIRÚRGICOS LTDA - ME

Brazil
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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 7Class II 1Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
323registered devices
Class I 261Class II 62
338 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States8 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil323 confirmed, 24 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO HOSPITALARES LTDA ME · FACON INDÚSTRIA E COMÉRCIO DE INSTRUMENTOS CIRÚRGICOS LTDA - ME · FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO-HOSPITALARES LTDA ME · MOCAR INSTRUMENTOS ODONTOLÓGICOS E CIRÚRGICOS LTDA - ME · CARPE DENT INSTRUMENTOS CIRÚRGICOS IMPORTAÇÃO E EXPORTAÇÃO LTDA - ME
Same-named companies — This database also contains companies with near-identical names: FAGA MEDICAL INDUSTRIA DE EQUIPAMENTOS E INSTRUMENTOS MEDICO HOSPITALARES LTDA ME, ME MEDICAL AG. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil

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 listed device types

Motor, Surgical Instrument, Ac-Powered 1Cannula, Ear 1Cannula, Surgical, General & Plastic Surgery 1Instrument, Manual, Surgical, General Use 1Snare, Surgical 1Tray, Surgical, Instrument 1Accessories, Catheter 1Bottle, Collection, Vacuum 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80826719006MICROCÂNULA DESCARTÁVEL FKMClass II
BR80826710020OCLUSOR ESTÉRIL FKMClass I
BR80826719005BISTURI DESCARTÁVEL FKMClass II

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