120500
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
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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
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
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Ackerstrasse 6, 8180 Bulach, Switzerland
Ackerstrasse 6, 8180 ๅธๆ่ตซ, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
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-ๆด่ฑๅ ็ถๅจ่ๆฏๆถ็ณป็ป (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)