HomeAustraliaImaxeon Pty, Ltd.

Imaxeon Pty, Ltd.

Australia · Rydalmere
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 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 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 1Class II 8
11 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
10valid device licences
Class II 10
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
18active ARTG entries
Class I 14IIa 3IIb 1
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
7active registrations
Class 2a 5Class 2b 2
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 States2 registration records, 2 510(k), 0 PMA
Brazil9 confirmed, 0 excluded
Manufacturer names merged into this page: IMAXEON PTY LTD

Company information

Country
Australia
City
Rydalmere

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
IMAXEON PTY LTD
ABN
93093950906
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2116

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

12024 · K241849
12025 · K252689

FDA listed device types

Injector, Contrast Medium, Automatic 1Injector And Syringe, Angiographic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)2025-09-24
USK241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)2024-11-05
BR80384389006Centargo - Linha do PacienteClass II
BR80384389007Centargo - Kit do diaClass II
BR80384389012MP1001: Seringa Multi-PacienteClass II

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