230441
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronary导管、血管、血管成形术、球囊、冠状动脉
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary. 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: Catheters, Vascular, Angioplasty, Balloon, Coronary
產品資訊： 导管、血管、血管成形术、球囊、冠状动脉
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
State
current
Status
N/A
Manufacturer (製造商)
Sino Medical Sciences Technology Inc.
赛诺医疗科学技术股份有限公司
China
中国
2nd Floor, TEDA Biopharm Res. Building B, #5 4th St. TEDA, Tianjin, China
中国天津埃及药品管理局生物制药研究部B座2楼,#5 4th St. T,埃及药品管理局
Authorised Representative (AR)
27863233
Regulatory Timeline
Registration Date
November 27, 2023
Expiry Date
November 27, 2028
Product Models
NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (NCP-2.00-08-RX, NCP-2.00-12-RX, NCP-2.00-15-RX, NCP-2.00-20-RX, NCP-2.25-08-RX, NCP-2.25-12-RX, NCP-2.25-15-RX, NCP-2.25-20-RX, NCP-2.50-08-RX, NCP-2.50-12-RX, NCP-2.50-15-RX, NCP-2.50-20-RX, NCP-2.75-08-RX, NCP-2.75-12-RX, NCP-2.75-15-RX, NCP-2.75-20-RX, NCP-3.00-08-RX, NCP-3.00-12-RX, NCP-3.00-15-RX, NCP-3.00-20-RX, NCP-3.25-08-RX, NCP-3.25-12-RX, NCP-3.25-15-RX, NCP-3.25-20-RX, NCP-3.50-08-RX, NCP-3.50-12-RX, NCP-3.50-15-RX, NCP-3.50-20-RX, NCP-3.75-08-RX, NCP-3.75-12-RX, NCP-3.75-15-RX, NCP-3.75-20-RX, NCP-4.00-08-RX, NCP-4.00-12-RX, NCP-4.00-15-RX, NCP-4.00-20-RX, NCP-4.50-08-RX, NCP-4.50-12-RX, NCP-4.50-15-RX, NCP-4.50-20-RX, NCP-5.00-08-RX, NCP-5.00-12-RX, NCP-5.00-15-RX, NCP-5.00-20-RX)
NC ROCKSTAR 不符合 PTCA 球囊扩张导管(NCP-2.00-08-RX、NCP-2.00-12-RX、NCP-2.00-15-RX、NCP-2.00-20-RX、NCP-2.25-08-RX、NCP-2.25-12-RX、NCP-2.25-15-RX、NCP-2.25-20-RX、NCP-2.25-20-RX. 50-08-RX, NCP-2.50-12-RX, NCP-2.50-15-RX, NCP-2.50-20-RX, NCP-2.75-08-RX, NCP-2.75-12-RX, NCP-2.75-15-RX, NCP-2.75-20-RX, NCP-3.00-08-RX, NCP-3.00-12-RX, NCP-3.00-15-RX, NCP-3.00-20-RX, NCP-3.25-08-RX, NCP-3.25-12-RX, NCP-3.25-15-RX, NCP-3.25-20-RX, NCP-3.50-08-RX, NCP-3.50-12-RX,NCP-3.50-15-RX、NCP-3.50-20-RX、NCP-3.75-08-RX、NCP-3.75-12-RX、NCP-3.75-15-RX、NCP-3.75-20-RX、NCP-4.00-08-RX、NCP-4.00-12-RX、NCP-4.00-15-RX、NCP-4.00-20-RX、NCP-4.50-08-RX、NCP-4.50-12-RX、NCP-4.50-15-RX、NCP-4.50-20-RX、NCP-5.00-08-RX、NCP-5.00-12-RX、NCP-5.00-15-RX、NCP-5.00-20-RX)