HomeAustralia4DMEDICAL LIMITED

4DMEDICAL LIMITED

Australia · Carlton
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
4listed device types
Class I 0Class II 4Class III 0
plus 9 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
5 including historic records
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 States9 registration records, 2 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: 4DMEDICAL LIMITED

Company information

Country
Australia
City
Carlton

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

ABN
31161684831
Registration status
Active
Legal form
Australian Public Company
Registered address
VIC, 3053

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

12023 · K232392
12025 · K251484

FDA listed device types

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. 1System, Image Processing, Radiological 1System, X-Ray, Tomography, Computed 1Automated Radiological Image Processing Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251484CT:VQ2025-08-28
USK232392CT Lung Ventilation Analysis Software (CT:V)2023-11-16
BR80117581086Imbio CT RV/LV SoftwareClass II
BR80117581087Imbio CT Lung Density Analysis SoftwareClass II
BR80117581088Imbio CT Lung Texture Analysis SoftwareClass II

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