HomeAustraliaActis Medical Pty., Ltd.

Actis Medical Pty., Ltd.

Australia · Torrensville
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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 5 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
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
23active ARTG entries
Class I 12IIa 6IIb 3Class Is (sterile) 2
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 States5 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: ACTIS MEDICAL
Same-named companies — This database also contains companies with near-identical names: ACTIS MEDICAL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Australia
City
Torrensville

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
ACTIS MEDICAL PTY LTD
ABN
20643388121
Registration status
Active
Legal form
Australian Private Company
Registered address
SA, 5025

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

12026 · K260090

FDA listed device types

Bit, Drill 1Passer 1Probe And Director, Gastro-Urology 1Orthopedic Manual Surgical Instrument 1Screw, Fixation, Bone 1Plate, Fixation, Bone 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260090SMART Osteotomy System2026-04-10

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