HomeBrazilICONACY ORTHOPEDIC IMPLANTS INDUSTRIA E COMERCIO DE PRODUTOS MEDICO HOSPITALARES LTDA

ICONACY ORTHOPEDIC IMPLANTS INDUSTRIA E COMERCIO DE PRODUTOS MEDICO HOSPITALARES LTDA

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
6510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
75registered devices
Class I 63Class II 12
94 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 States0 registration records, 6 510(k), 0 PMA
Brazil75 confirmed, 0 excluded
Manufacturer names merged into this page: ICONACY ORTHOPEDIC IMPLANTS INDUSTRIA E COMERCIO DE PRODUTOS MEDICO HOSPITALARES LTDA

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 510(k) clearances by year

12012 · K121034
12013 · K131279
22014 · K132572
22016 · K160266

Registration details (sample)

MarketIdentifierNameClass / date
USK160266ICONACY(TM) I-Hip(TM)2016-04-08
USK151307ICONACY(TM) I-Hip (TM)2016-02-26
USK132572I-HIP TOTAL HIP SYSTEM2014-03-28
BR8029761011511-18019-900-03 - Kit de Instrumentais I - Hip 3 - Acetabular InstrumeClass I
BR80297610116Cânulas para ArtroscopiaClass II
BR80297610117Equipo de Irrigação para ArtroscopiaClass II

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