HomeAustraliaSaluda Medical Pty. Ltd.

Saluda Medical Pty. Ltd.

Australia · Macquarie Park New South
✓ 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
3listed device types
Class I 0Class II 0Class III 3
plus 3 registration records and 0 510(k), 43 PMA
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
50active ARTG entries
Class I 25Class III 18Active implantable 1IIa 3IIb 2Class Is (sterile) 1
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 States3 registration records, 0 510(k), 43 PMA
Manufacturer names merged into this page: Saluda Medical Pty. Ltd.

Company information

Country
Australia
City
Macquarie Park New 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
SALUDA MEDICAL PTY LIMITED
ABN
14145902272
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2113

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

FDA listed device types

Stimulator, Electrical, Implantable, For Incontinence 1Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy 1Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 1

Similar companies

ALLICO PACKAGING PTY LTD
Australia · markets 0
Amos Scientific PTY. LTD
Australia · markets 2
Austofix Pty. Ltd.
Australia · markets 0
Axxin Pty Ltd
Australia · markets 1
Care Essentials Pty Ltd
Australia · markets 10
CMS SciDoc Pty Ltd
Australia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →