HomeBrazilAUSTIN MEDICAL INNOVATION LTDA

AUSTIN MEDICAL INNOVATION 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
6listed device types
Class I 4Class II 2Class III 0
plus 6 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class I 1Class II 30
this export covers Class I / II only (the cadastro route)
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 States6 registration records, 1 510(k), 0 PMA, 12 excluded
Brazil31 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Austin Medical, Inc. · AUSTIN MEDICAL INNOVATION 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

12006 · K061422

FDA listed device types

Aspiration Tray 1Fiber, Medical, Absorbent 1Support, Patient Position 1Kit, Surgical Instrument, Disposable 1General Surgery Tray 1Drape, Surgical, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
USK061422SURGICAL DRAPES2006-09-25
BR82900399007Kit Cânula de Discectomia Percutânea de Disco Lombar ASTClass II
BR82900399008Kit Cânula de Discectomia Percutânea de Disco Cervical ASTClass II
BR82900399009Kit Cânula de ACESSO ASTClass II

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