160427
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
Elixir Medical Corporation·IV·Hong Kong MDACS·Registered October 19, 2021
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
- Elixir Medical CorporationElixir Medical Corporation
- Country
- United States美国
- Address
- 920 N. McCarthy Boulevard, Suite 100, Milpitas, California 95035, USA920 N. McCarthy Boulevard, Suite 100, 米尔皮塔斯, 加利福尼亚州 95035, 美国
Authorised representative (AR)
- Name
- Emergo Hong Kong Limited埃默高香港有限公司
- Phone
- 22769196
Regulatory timeline
- Registration date
- October 19, 2021
- Expiry date
- December 13, 2026
Product models
DESyne Novolimus Eluting Coronary Stent System (SER2514, SER2518, SER2523, SER2528, SER2532, SER2538, SER2714, SER2718, SER2723, SER2728, SER2732, SER2738, SER3014, SER3018, SER3023, SER3028, SER3032, SER3038, SER3514, SER3518, SER3523, SER3528, SER3532, SER3538, SER4014, SER4018, SER4023, SER4028, SER4032, SER4038, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038), DESyne X2 Novolimus Eluting Coronary Stent System (SZR2214, SZR2218, SZR2223, SZR2228, SZR2232, SZR2238, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038)
德炔诺莫司洗脱冠状动脉支架系统 (SER2514, SER2518, SER2523, SER2528, SER2532, SER2538, SER2714, SER2718, SER2723, SER2728, SER2732, SER2738, SER3014, SER3018, SER3023, SER3028, SER3032, SER3038, SER3514, SER3518, SER3523, SER3528, SER3532 SER3538, , , , , SER4014, SER4018, SER4023, SER4028, SER4032, SER4038, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038), DESyne X2 新莫司洗脱冠状动脉支架系统 (SZR2214, SZR2218, SZR2223, SZR2228, SZR2232, SZR2238, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038)
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