180242
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)
Envision Scientific Pvt. Ltd.
Envision Scientific Pvt. Ltd.
India
ๅฐๅบฆ
Office 1~3, Silver Palm II, Near Snehmilan Garden, Kadampalli, Nanpura, Surat - 395 001, Gujarat, India
ๅๅ
ฌๅฎค 1~3, ้ถๆฃๆฆไบๅท, ่ฟๆฏๅ
็ฑณๅ
ฐ่ฑๅญ, ๅกไธนๅธๅฉ, ๅๆฎๆ, ่ๆ็น - 395 001, ๅคๅๆ็น้ฆ, ๅฐๅบฆ
Authorised Representative (AR)
Angeion Medical HK Limited
ๅฎๅฅๅป็้ฆๆธฏๆ้ๅ
ฌๅธ
96886105
Regulatory Timeline
Registration Date
August 29, 2023
Expiry Date
August 06, 2028
Product Models
Abluminus Sirolimus Eluting Coronary Stent System (EAB22508, EAB25008, EAB27508, EAB30008, EAB35008, EAB40008, EAB45008, EAB50008, EAB22512, EAB25012, EAB27512, EAB30012, EAB35012, EAB40012, EAB45012, EAB50012, EAB22516, EAB25016, EAB27516, EAB30016, EAB35016, EAB40016, EAB45016, EAB50016, EAB22520, EAB25020, EAB27520, EAB30020, EAB35020, EAB40020, EAB45020, EAB50020, EAB22524, EAB25024, EAB27524, EAB30024, EAB35024, EAB40024, EAB22528, EAB25028, EAB27528, EAB30028, EAB35028, EAB40028, EAB22532, EAB25032, EAB27532, EAB30032, EAB35032, EAB40032, EAB22536, EAB25036, EAB27536, EAB30036, EAB35036, EAB40036, EAB22540, EAB25040, EAB27540, EAB30040, EAB35040, EAB40040, EAB25044, EAB30044, EAB35044, EAB40044, EAB25048, EAB30048, EAB35048, EAB40048, EAB25052, EAB30052, EAB35052, EAB40052)
่ฅฟ็ฝ่ซๅธๆด่ฑๅ ็ถๅจ่ๆฏๆถ็ณป็ป (EAB22508, EAB25008, EAB27508, EAB30008, EAB35008, EAB40008, EAB45008, EAB50008, EAB22512, EAB25012, EAB27512, EAB30012, EAB35012, EAB40012, EAB45012, EAB50012, EAB22516, EAB25016, EAB27516, EAB30016, EAB35016, EAB40016, EAB45016, EAB50016, EAB22520, EAB25020, EAB27520, EAB30020, EAB35020, EAB40020, EAB45020, EAB50020, EAB22524, EAB25024, EAB27524, EAB30024, EAB35024, EAB40024, EAB22528, EAB25028, EAB27528, EAB30028, EAB35028, EAB40028, EAB22532, EAB25032, EAB27532, EAB30032, EAB35032, EAB40032, EAB22536, EAB25036, EAB27536, EAB30036, EAB35036, EAB40036, EAB22540, EAB25040, EAB27540, EAB30040, EAB35040, EAB40040, EAB25044, EAB30044, EAB35044, EAB40044, EAB25048, EAB30048, EAB35048, EAB40048, EAB25052, EAB30052, EAB35052, EAB40052)