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Home›Brazil›Orthometric - Industria E Comercio DE Produtos Medicos

Orthometric - Industria E Comercio DE Produtos Medicos

Brazil · Marilia
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
43registered devices
Class I 18Class II 25
44 including historic records
SASaudi ArabiaSFDA
12registered 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, 1 510(k), 0 PMA, 1 excluded
Brazil43 confirmed, 0 excluded
Saudi Arabia12 confirmed, 0 excluded
Manufacturer names merged into this page: ORTHOMETRIC - INDÚSTRIA E COMÉRCIO DE PRODUTOS MÉDICOS E ODONTOLÓGICOS LTDA · Orthometric Industria e comercio de produtos medicos e odontologicos Ltda · Orthometric Industria e Comercio de Produtos Medicos e Odontologicos Ltda

Company information

Country
Brazil
City
Marilia

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

12023 · K222847

Registration details (sample)

MarketIdentifierNameClass / date
USK222847Ceramic Brackets Orthometric2023-05-04
BR80328810085POSICIONADOR DE ELÁSTICOSClass I
BR80328810076INSTRUMENTOS PARA ORTODONTIAClass I
BR80328810078ORTHOMETRIC SS - GOLD EDITIONClass I
SAME0000006949SFDAA00002Orthodontic Bracket—
SAME0000006951SFDAA00002Elastics—

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