160428
IV
Expired.
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
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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
Expired.
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
September 22, 2017
Expiry Date
December 13, 2021
Product Models
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (SPR2514, SPR2518, SPR2523, SPR2528, SPR2714, SPR2718, SPR2723, SPR2728, SPR3014, SPR3018, SPR3023, SPR3028, SPR3214, SPR3218, SPR3223, SPR3228, SPR3514, SPR3518, SPR3523, SPR3528), DESolve XL Novolimus Eluting Bioresorbable Coronary Scaffold System (SPR3714, SPR3718, SPR3723, SPR3728, SPR4014, SPR4018, SPR4023, SPR4028), DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System (SVR2514, SVR2518, SVR2523, SVR2528, SVR2714, SVR2718, SVR2723, SVR2728, SVR3014, SVR3018, SVR3023, SVR3028, SVR3214, SVR3218, SVR3223, SVR3228, SVR3514, SVR3518, SVR3523, SVR3528), DESolve Cx Plus Novolimus Eluting Bioresorbable Coronary Scaffold System (BFR2514, BFR2518, BFR2523, BFR2528, BFR2714, BFR2718, BFR2723, BFR2728, BFR3014, BFR3018, BFR3023, BFR3028, BFR3214, BFR3218, BFR3223, BFR3228, BFR3514, BFR3518, BFR3523, BFR3528)
DESolve Novolimus ๆด่ฑ็็ฉๅฏๅธๆถๅ ็ถๅจ่ๆฏๆถ็ณป็ป (SPR2514, SPR2518, SPR2523, SPR2528, SPR2714, SPR2718, SPR2723, SPR2728, SPR3014, SPR3018, SPR3023, SPR3028, SPR3214, SPR3218, SPR3223, SPR3228, SPR3514, SPR3518, SPR3523, SPR3528), DESolve XL ๆฐ่ซๅธๆด่ฑ็็ฉๅฏๅธๆถๅ ็ถๅจ่ๆฏๆถ็ณป็ป (SPR3714, SPR3718, SPR3723, SPR3728, SPR4014, SPR4018, SPR4023, SPR4028), DESolve Cx ๆฐ่ซๅธๆด่ฑ็็ฉๅฏๅธๆถๅ ็ถๅจ่ๆฏๆถ็ณป็ป (SVR2514, SVR2518, SVR2523, SVR2528, SVR2714, SVR2718, SVR2723, SVR2728, SVR3014, SVR3018, SVR3023, SVR3028, SVR3214, SVR3218, SVR3223, SVR3228, SVR3514, SVR3518, SVR3523, SVR3528), DESolve Cx Plus Novolimus ๆด่ฑ็็ฉๅฏๅธๆถๅ ็ถๅจ่ๆฏๆถ็ณป็ป (B่้ฆๅ
ฌๆฅ 2514, B่้ฆๅ
ฌๆฅ 2518, B่้ฆๅ
ฌๆฅ 2523, B่้ฆๅ
ฌๆฅ 2528, B่้ฆๅ
ฌๆฅ 2714, B่้ฆๅ
ฌๆฅ 2718, B่้ฆๅ
ฌๆฅ 2723, B่้ฆๅ
ฌๆฅ 2728, B่้ฆๅ
ฌๆฅ 3014, B่้ฆๅ
ฌๆฅ 3018, B่้ฆๅ
ฌๆฅ 3023, B่้ฆๅ
ฌๆฅ 3028, B่้ฆๅ
ฌๆฅ 3214, B่้ฆๅ
ฌๆฅ 3218, B่้ฆๅ
ฌๆฅ 3223, B่้ฆๅ
ฌๆฅ 3228, B่้ฆๅ
ฌๆฅ 3514, B่้ฆๅ
ฌๆฅ 3518, B่้ฆๅ
ฌๆฅ 3523, B่้ฆๅ
ฌๆฅ 3528)