230438
III
current
Injectors, Contrast Media, Computed Tomography注射器、造影剂、计算机断层扫描
This profile provides complete Hong Kong MDACS registration information for Injectors, Contrast Media, Computed Tomography. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Injectors, Contrast Media, Computed Tomography
產品資訊： 注射器、造影剂、计算机断层扫描
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17969
Product Code Detail
17969 Injectors, Contrast Media, Computed Tomography
State
current
Status
N/A
Manufacturer (製造商)
Imaxeon Pty Ltd
Imaxeon Pty Ltd
Australia
澳大利亚
Unit 1, 38-46 South Street, Rydalmere, New South Wales, 2116, Australia
Unit 1, 38-46 South Street, Rydalmere, New South Wales, 2116, 澳大利亚
Authorised Representative (AR)
27863233
Regulatory Timeline
Registration Date
November 22, 2023
Expiry Date
November 22, 2028
Product Models
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)
MEDRAD Salient 造影剂单基本型 (DC009S)、MEDRAD Salient 造影剂双基本型 (DC009D)、MEDRAD Salient 造影剂单型,带无线 RCU (DC009SW)、MEDRAD Salient 造影剂双型,带无线 RCU (DC009DW)、190 ml 注射器,带快速填充管 (QFT) (ZY6322)、190 ml 带尖刺注射器 (ZY6323)、190 ml 带尖刺注射器 150 cm 连接管 (ZY6324), 190 ml 注射器,带快速填充管 (QFT) 150 cm 连接管 (ZY6325),150 cm 延长管 单根 (ZY5151),150 cm 延长管 T 型接头 (ZY5152),150 cm Y 延长管 (ZY5154)