120500
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
Biotronik AG·IV·Hong Kong MDACS·Registered January 19, 2023
Device overview
- Risk class
- IV
- Product code
- 20383
- State
- current
- Status
- N/A
- Product code detail
- 20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Manufacturer (製造商)
- Name
- Biotronik AGBiotronik Ag
- Country
- Switzerland瑞士
- Address
- Ackerstrasse 6, 8180 Bulach, SwitzerlandAckerstrasse 6, 8180 布拉赫, 瑞士
Authorised representative (AR)
- Name
- Biotronik Hong Kong Limited百多力香港有限公司
- Phone
- 31904500
Regulatory timeline
- Registration date
- January 19, 2023
- Expiry date
- March 01, 2028
Product models
Orsiro Sirolimus-Eluting Coronary Stent System (364469, 364470, 364471, 364472, 364473, 364474, 364475, 364476, 364477, 364478, 364479, 364480, 364481, 364482, 364483, 364484, 364485, 364486, 364487, 364488, 364489, 364490, 364491, 364492, 364499, 364500, 364501, 364502, 364503, 364504, 364505, 364506, 364507, 364508, 364509, 364510, 364511, 364512, 364513, 364514, 364515, 364516, 391234, 391235, 391236, 391237, 391018, 391019, 391238, 391239, 391240, 391241, 391020, 391021)
Orsiro Sirolimus-洗脱冠状动脉支架系统 (364469, 364470, 364471, 364472, 364473, 364474, 364475, 364476, 364477, 364478, 364479, 364480, 364481, 364482, 364483, 364484, 364485, 364486, 364487, 364488, 364489, 364490, 364491, 364492 , 364499, 364500, 364501, 364502, 364503, 364504, 364505, 364506, 364507, 364508, 364509, 364510, 364511, 364512, 364513, 364514, 364515, 364516, 391234, 391235, 391236, 391237, 391018, 391019, 391238, 391239, 391240, 391241, 391020, 391021)
About this record
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