160427
IV
current
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting่ก็ฎกๆฏๆถใๅ ็ถๅจ่ๆฏๆถใ็ๅๆฉๅผ ๆฏๆถใ่ฏ็ฉๆด่ฑๆฏๆถ
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
็ขๅ่ณ่จ๏ผ ่ก็ฎกๆฏๆถใๅ ็ถๅจ่ๆฏๆถใ็ๅๆฉๅผ ๆฏๆถใ่ฏ็ฉๆด่ฑๆฏๆถ
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 (่ฃฝ้ ๅ)
Elixir Medical Corporation
Elixir Medical Corporation
United States
็พๅฝ
920 N. McCarthy Boulevard, Suite 100, Milpitas, California 95035, USA
920 N. McCarthy Boulevard, Suite 100, ็ฑณๅฐ็ฎๅกๆฏ, ๅ ๅฉ็ฆๅฐผไบๅท 95035, ็พๅฝ
Authorised Representative (AR)
Emergo Hong Kong Limited
ๅ้ป้ซ้ฆๆธฏๆ้ๅ
ฌๅธ
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)
ๅพท็่ฏบ่ซๅธๆด่ฑๅ ็ถๅจ่ๆฏๆถ็ณป็ป (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 ๆฐ่ซๅธๆด่ฑๅ ็ถๅจ่ๆฏๆถ็ณป็ป (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)