HomeAustraliaAUS Systems Pty Limited

AUS Systems Pty Limited

Australia · Allenby Gardens South
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel — 4 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
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered 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
8active ARTG entries
Class I 7IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States3 registration records, 1 510(k), 0 PMA, 1 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: AUS SYSTEMS PTY LTD. · Anteris Aus Operations Pty Ltd · AUS Systems Pty Limited

Company information

Country
Australia
City
Allenby Gardens South

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.

Business registration

Legal name
AUS SYSTEMS PTY. LIMITED.
ABN
71008009774
Registration status
Active
Legal form
Australian Private Company
Registered address
SA, 5009

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006 · K062159

FDA listed device types

Dilator, Rectal 1Intracardiac Patch Or Pledget, Biologically Derived 1Instrument, Biopsy, Suction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK062159RB12 SUCTION RECTAL BIOPSY SYSTEM2006-09-05
SAME0000003226SFDAA00001RBI2
SAME0000003226SFDAA00001RBI2

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