220330
IV
current
Stents, Vascular, Peripheral, Balloon-Expandableๆฏๆถ,่ก็ฎกๆฏๆถ,ๅคๅจๆฏๆถ,็ๅๆฉๅผ ๆฏๆถ
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Peripheral, Balloon-Expandable. 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, Peripheral, Balloon-Expandable
็ขๅ่ณ่จ๏ผ ๆฏๆถ,่ก็ฎกๆฏๆถ,ๅคๅจๆฏๆถ,็ๅๆฉๅผ ๆฏๆถ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20429
Product Code Detail
20429 Stents, Vascular, Peripheral, Balloon-Expandable
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Elixir Medical Corporation
Elixir Medical Corporation
United States
็พๅฝ
920 N McCarthy Blvd., Suite 100, Milpitas, CA 95035, USA
920 N McCarthy Blvd., Suite 100, ็ฑณๅฐ็ฎๅกๆฏ, CA 95035, ็พๅฝ
Authorised Representative (AR)
Emergo Hong Kong Limited
ๅ้ป้ซ้ฆๆธฏๆ้ๅ
ฌๅธ
22769196
Regulatory Timeline
Registration Date
October 18, 2022
Expiry Date
October 18, 2027
Product Models
DynamX Sprint Sirolimus Eluting BTK Bioadaptor System (VLR2014, VLR2214, VLR2514, VLR2714, VLR2018, VLR2218, VLR2518, VLR2718, VLR2023, VLR2223, VLR2523, VLR2723, VLR2028, VLR2228, VLR2528, VLR2728, VLR2032, VLR2232, VLR2532, VLR2732, VLR2038, VLR2238, VLR2538, VLR2738, VLR2043, VLR2243, VLR2543, VLR2743, VLR2046, VLR2246, VLR2546, VLR2746, VLR2048, VLR2248, VLR2548, VLR2748, VLR3014, VLR3514, VLR4015, VLR3018, VLR3518, VLR4018, VLR3023, VLR3523, VLR4023, VLR3028, VLR3528, VLR4028, VLR3032, VLR3532, VLR4032, VLR3038, VLR3538, VLR4038, VLR3043, VLR3543, VLR4041, VLR3046, VLR3546, VLR3048, VLR3548)
DynamX Sprint ่ฅฟ็ฝ่ซๅธๆด่ฑ BTK ็็ฉ้้
ๅจ็ณป็ป (VLR2014, VLR2214, VLR2514, VLR2714, VLR2018, VLR2218, VLR2518, VLR2718, VLR2023, VLR2223, VLR2523, VLR2723, VLR2028, VLR2228, VLR2528, VLR2728, VLR2032, VLR2232, VLR2532, VLR2732, VLR2038, VLR2238, VLR2538 , VLR2738, VLR2043, VLR2243, VLR2543, VLR2743, VLR2046, VLR2246, VLR2546, VLR2746, VLR2048, VLR2248, VLR2548, VLR2748, VLR3014, VLR3514, VLR4015, VLR3018, VLR3518, VLR4018, VLR3023, VLR3523, VLR4023, VLR3028, VLR3528, VLR4028, VLR3032, VLR3532ใVLR4032ใVLR3038ใVLR3538ใVLR4038ใVLR3043ใVLR3543ใVLR4041ใVLR3046ใVLR3546ใVLR3048 VLR3548)