230272
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)
Bayer Medical Care Inc.
Bayer Medical Care Inc.
United States
美国
1 Bayer Drive, Indianola, Pennsylvania, 15051-0780, USA
1 Bayer Drive, 印第安诺拉, 宾夕法尼亚州, 15051-0780, 美国
Authorised Representative (AR)
27863233
Regulatory Timeline
Registration Date
August 24, 2023
Expiry Date
August 24, 2028
Product Models
MEDRAD Stellant CT Injection System with Certegra Workstation (SCT 310), MEDRAD Stellant Imaging System Interface (ISI) (ISI 700, ISI 800), Connect.CT Module (Connect.CT), Personalized Patient Protocol Technology (P3T) (MIS P3TC, UFK P3TC, MIS P3TA, UFK P3TA, MIS P3TPA, UFK P3TPA), MEDRAD Stellant Sterile Disposable Syringe (SSS-QFT, SSS-CTP-QFT, SSS-SPK, SSS-CTP-SPK, SDS-CTP-QFT, SDS-CTP-SPK, SDS-TRF-CV, SDS-CTP-SCS), MEDRAD Stellant Low Pressure Connector Tubing with Prime Tube (SSS-LP-60, SSS-LP-60-T), Low Pressure Connector Tubing Integral \"T\" with Check Valve (LP-96-T-CV), MEDRAD Stellant 250cm Single Patient Disposable (SPD 250), MEDRAD Stellant Multi-Patient Kit (SDS MP1), Certegra Imaging System Interface Module for Certegra Workstation (ISI 900G, ISI 900H, ISI 900S, ISI 900T, ISI 900U)
带 Certegra 工作站的 MEDRAD Stellant CT 注射系统 (SCT 310)、MEDRAD Stellant 成像系统接口 (ISI)(ISI 700、ISI 800)、Connect.CT 模块 (Connect.CT)、个性化患者协议技术 (P3T)(MIS P3TC、UFK P3TC、MIS P3TA、UFK P3TA、MIS P3TPA、UFK P3TPA)、MEDRAD Stellant 无菌一次性注射器(SSS-QFT、SSS-CTP-QFT、SSS-SPK、SSS-CTP-SPK、SDS-CTP-QFT、SDS-CTP-SPK、SDS-TRF-CV、SDS-CTP-SCS)、MEDRAD Stellant 带Prime 管的低压连接器管(SSS-LP-60、 SSS-LP-60-T)、带止回阀的低压接头管道整体 \'T"型 (LP-96-T-CV)、MEDRAD Stellant 250cm 一次性单人患者 (SPD 250)、MEDRAD Stellant 多患者套件 (SDS MP1)、用于 Certegra 工作站的 Certegra 成像系统接口模块(ISI 900G、ISI 900H、ISI 900S、ISI 900T、ISI 900U)