Medical Device Division · registration 230438ActiveImaxeon Pty
Hong KongInjectors, Contrast Media, Computed TomographyClass IIIImaxeon Pty Ltd
Official record identity
- MDACS listing number
- 230438
- Model name
- MEDRAD Salient Contrast Injector Single Basic (DC009S), MEDRAD Salient Contrast Injector Dual Basic (DC009D), MEDRAD Salient Contrast Injector Single with Wireless RCU (DC009SW), MEDRAD Salient Contrast Injector Dual with Wireless RCU (DC009DW), 190 ml Syringe with quick fill tube (QFT) (ZY6322), 190 ml Syringe with Spike (ZY6323), 190 ml Syringe with Spike 150 cm Connecting Tube (ZY6324), 190 ml Syringe with quick fill tube (QFT) 150 cm Connecting Tube (ZY6325), 150 cm Extension Tube Single (ZY5151), 150 cm Extension Tube T-connector (ZY5152), 150 cm Y Extension Tube (ZY5154)
- Registration date
- January 23, 2025
- Expiry date
- November 22, 2028
- Source update date
- April 02, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Prism Technologies Limited
- Manufacturer
- Imaxeon Pty Ltd
Official description
Injectors, Contrast Media, Computed Tomography
Additional source fields
- AMD nomenclature code
- 17969
- Traditional Chinese local responsible person
- 稜科有限公司
- Local responsible person phone
- 27863233
- Published manufacturer address
- Unit 1, 38-46 South Street, Rydalmere, New South Wales, 2116, Australia
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.