180243
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Deliveryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ่ฏ็ฉ่พ้
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery. 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: Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18645
Product Code Detail
18645 Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
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 Sneh Milan Garden, Kadampalli, Nanpura, Surat - 395 001, Gujarat, India
ๅๅ
ฌๅฎค 1~3, ้ถๆฃๆฆ-II, ่ฟ Sneh ็ฑณๅ
ฐ่ฑๅญ, ๅกไธนๅธๅฉ, ๅๆฎๆ, ่ๆ็น - 395 001, ๅคๅๆ็น้ฆ, ๅฐๅบฆ
Authorised Representative (AR)
Angeion Medical HK Limited
ๅฎๅฅๅป็้ฆๆธฏๆ้ๅ
ฌๅธ
96886105
Regulatory Timeline
Registration Date
February 08, 2023
Expiry Date
August 06, 2028
Product Models
Magic Touch Sirolimus Coated Balloon Catheter (CMT15010, CMT20010, CMT22510, CMT25010, CMT27510, CMT30010, CMT32510, CMT35010, CMT40010, CMT15015, CMT20015, CMT22515, CMT25015, CMT27515, CMT30015, CMT32515, CMT35015, CMT40015, CMT15020, CMT20020, CMT22520, CMT25020, CMT27520, CMT30020, CMT32520, CMT35020, CMT40020, CMT15025, CMT20025, CMT22525, CMT25025, CMT27525, CMT30025, CMT32525, CMT35025, CMT40025, CMT15030, CMT20030, CMT22530, CMT25030, CMT27530, CMT30030, CMT32530, CMT35030, CMT40030, CMT15035, CMT20035, CMT22535, CMT25035, CMT27535, CMT30035, CMT32535, CMT35035, CMT40035, CMT15040, CMT20040, CMT22540, CMT25040, CMT27540, CMT30040, CMT32540, CMT35040, CMT40040)
้ญๆฏ่งฆๆธ่ฅฟ็ฝ่ซๅธๆถๅฑ็ๅๅฏผ็ฎก (CMT15010, CMT20010, CMT22510, CMT25010, CMT27510, CMT30010, CMT32510, CMT35010, CMT40010, CMT15015, CMT20015, CMT22515, CMT25015, CMT27515, CMT30015, CMT32515, CMT35015, CMT40015, CMT15020, CMT20020, CMT22520, CMT25020, CMT27520, CMT30020, CMT32520, CMT35020, CMT40020, CMT15025, CMT20025, CMT22525, CMT25025, CMT27525, CMT30025, CMT32525, CMT35025, CMT40025, CMT15030, CMT20030, CMT22530, CMT25030, CMT27530, CMT30030, CMT32530, CMT35030, CMT40030, CMT15035ใCMT20035ใCMT22535ใCMT25035ใCMT27535ใCMT30035ใCMT32535ใCMT35035ใCMT40035ใCMT15040ใCMT20040ใCMT22540ใCMT25040ใCMT27540ใCMT30040ใCMT32540ใCMT35040ใCMT40040)