180486
IV
current
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting. 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: Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
產品資訊： 血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20383
Product Code Detail
20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
State
current
Status
N/A
Manufacturer (製造商)
Medinol Ltd.
Medinol Ltd.
Israel
以色列
Beck-Tech Building. Har Hotzvim B, Hartom St. 8, 9777508 Jerusalem, Israel
贝克科技大厦.Har Hotzvim B, Hartom St. 8, 9777508 耶路撒冷, 以色列
Authorised Representative (AR)
27863233
Regulatory Timeline
Registration Date
December 06, 2023
Expiry Date
December 06, 2028
Product Models
EluNIR Ridaforolimus Eluting Coronary Stent System (LUN225L081N, LUN225L121N, LUN225L151N, LUN225L171N, LUN225L201N, LUN225L241N, LUN225L281N, LUN225L331N, LUN250R08IN, LUN250R12IN, LUN250R15IN, LUN250R17IN, LUN250R20IN, LUN250R24IN, LUN250R28IN, LUN250R33IN, LUN275R08IN, LUN275R12IN, LUN275R15IN, LUN275R17IN, LUN275R20IN, LUN275R24IN, LUN275R28IN, LUN275R33IN, LUN275R38IN, LUN275R44IN, LUN300R08IN, LUN300R12IN, LUN300R15IN, LUN300R17IN, LUN300R20IN, LUN300R24IN, LUN300R28IN, LUN300R33IN, LUN300R38IN, LUN300R44IN, LUN350R08IN, LUN350R12IN, LUN350R15IN, LUN350R17IN, LUN350R20IN, LUN350R24IN, LUN350R28IN, LUN350R33IN, LUN350R38IN, LUN350R44IN, LUN400R08IN, LUN400R12IN, LUN400R15IN, LUN400R17IN, LUN400R20IN, LUN400R24IN, LUN400R28IN, LUN400R33IN, LUN400R38IN, LUN400R44IN)
EluNIR 利达福洛莫司洗脱冠状动脉支架系统 (LUN225L081N, LUN225L121N, LUN225L151N, LUN225L171N, LUN225L201N, LUN225L241N, LUN225L281N, LUN225L331N, LUN250R08IN, LUN250R12IN, LUN250R15IN, LUN250R17IN, LUN250R20IN, LUN250R24IN, LUN250R28IN, LUN250R33IN, LUN275R08IN, LUN275R12IN, LUN275R15IN, LUN275R17IN, LUN275R20IN, LUN275R24IN, LUN275R28IN, LUN275R33IN, LUN275R38IN, LUN275R44IN, LUN300R08IN, LUN300R12IN, LUN300R15IN, LUN300R17IN, LUN300R20IN, LUN300R24IN, LUN300R28IN,LUN300R33IN、LUN300R38IN、LUN300R44IN、LUN350R08IN、LUN350R12IN、LUN350R15IN、LUN350R17IN、LUN350R20IN、LUN350R24IN、LUN350R28IN、LUN350R33IN、LUN350R38IN、LUN350R44IN、LUN400R08IN、LUN400R12IN、LUN400R15IN、LUN400R17IN、LUN400R20IN、LUN400R24IN、LUN400R28IN、LUN400R33IN、LUN400R38IN、LUN400R44IN)