HomeBrazilAditek do Brasil Ltda

Aditek do Brasil Ltda

Brazil · Cravinhos Sao Paulo
✓ 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
12listed device types
Class I 9Class II 3Class III 0
plus 13 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
37registered devices
Class I 13Class II 24
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
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 States13 registration records, 0 510(k), 0 PMA
Brazil37 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: ADITEK DO BRASIL, SA · ADITEK DO BRASIL S.A · Aditek do Brasil Ltda
Same-named companies — This database also contains companies with near-identical names: ADITEK DO BRASIL S.A. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil
City
Cravinhos 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 listed device types

showing 8 of 12
Spring, Orthodontic 1Maintainer, Space Preformed, Orthodontic 1Tube, Orthodontic 1Instrument, Ligature Tucking, Orthodontic 1Handle, Instrument, Dental 1Band, Elastic, Orthodontic 1Bracket, Metal, Orthodontic 1Retainer, Screw Expansion, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10331430018BRACKETS CERÂMICOS ADITEKClass II
BR10331430012ELASTICOS ORTODONTICOS ADITEKClass II
BR10331430013BANDAS ORTODONTICAS ADITEKClass II
SAME0000007675SFDAA00001ARCHWIRE ORTHODONTIC
SAME0000007952SFDAA00001ORTHODONTIC Brackets

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