HomeAustraliaHarrison-AI Medical Pty, Ltd.

Harrison-AI Medical Pty, Ltd.

Australia · Sydney New South
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Singapore, Australia — 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
2listed device types
Class I 0Class II 2Class III 0
plus 9 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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIb 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 States9 registration records, 1 510(k), 0 PMA, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: Harrison-AI Medical Pty Ltd

Company information

Country
Australia
City
Sydney 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
HARRISON-AI MEDICAL PTY LTD
ABN
92635645260
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2000

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 · K253818

FDA listed device types

Radiological Computer-Assisted Prioritization Software For Lesions 1Radiological Computer-Assisted Triage And Notification Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253818Annalise Enterprise2026-03-03

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