220224
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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ่ฏ็ฉ่พ้
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)
MedAlliance CardioVascular SA
MedAlliance CardioVascular SA
Switzerland
็ๅฃซ
Rue de Rive 5
1260 Nyon
Switzerland
Rive 5 ่ก
1260 ๅฐผๆฐธ
็ๅฃซ
Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธ่ๅป็ๆ้ๅ
ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
August 18, 2022
Expiry Date
August 18, 2027
Product Models
Selution SLR 014 PTCA Balloon Catheter (SC14-150010, SC14-150015, SC14-150020, SC14-150025, SC14-150030, SC14-150035, SC14-150040, SC14-200010, SC14-200015, SC14-200020, SC14-200025, SC14-200030, SC14-200035, SC14-200040, SC14-225010, SC14-225015, SC14-225020, SC14-225025, SC14-225030, SC14-225035, SC14-225040, SC14-250010, SC14-250015, SC14-250020, SC14-250025, SC14-250030, SC14-250035, SC14-250040, SC14-275010, SC14-275015, SC14-275020, SC14-275025, SC14-275030, SC14-275035, SC14-275040, SC14-300010, SC14-300015, SC14-300020, SC14-300025, SC14-300030, SC14-300035, SC14-300040, SC14-325010, SC14-325015, SC14-325020, SC14-325025, SC14-325030, SC14-325035, SC14-325040, SC14-350010, SC14-350015, SC14-350020, SC14-350025, SC14-350030, SC14-350035, SC14-350040, SC14-375010, SC14-375015, SC14-375020, SC14-375025, SC14-375030, SC14-375035, SC14-375040, SC14-400010, SC14-400015, SC14-400020, SC14-400025, SC14-400030, SC14-400035, SC14-400040, SC14-450010, SC14-450015, SC14-450020, SC14-450025, SC14-450030, SC14-450035, SC14-450040, SC14-500010, SC14-500015, SC14-500020, SC14-500025, SC14-500030, SC14-500035, SC14-50040)
ๆด่ฑSLR 014 PTCA็ๅๅฏผ็ฎก(SC14-150010,SC14-150015,SC14-150020,SC14-150025,SC14-150030,SC14-150035,SC14-150040,SC14-200010,SC14-200015,SC14-200020,SC14-200025,SC14-200030,SC14-200035,SC14-200040,SC14-225010,SC14-225015-225020 , SC14-225025, SC14-225030, SC14-225035, SC14-225040, SC14-250010, SC14-250015, SC14-250020, SC14-250025, SC14-250030, SC14-250035, SC14-250040, SC14-275010, SC14-275015, SC14-275020, SC14-275025, SC14-275030, SC14-275035,SC14-275040, SC14-300010, SC14-300015, SC14-300020, SC14-300025, SC14-300030, SC14-300035, SC14-300040, SC14-325010, SC14-325015, SC14-325020, SC14-325025, SC14-325030, SC14-325035, SC14-325040, SC14-350010, SC14-350015, SC14-3500 0025 , SC14-350030, SC14-350035, SC14-350040, SC14-375010, SC14-375015, SC14-375020, SC14-375025, SC14-375030, SC14-375035, SC14-375040, SC14-400010, SC14-400015, SC14-400020, SC14-400025, SC14-400030, SC14-400035, SC14-400040, SC14-450010,SC14-450015, SC14-450020, SC14-450025, SC14-450030, SC14-450035, SC14-450040, SC14-500010, SC14-500015, SC14-500020, SC14-500025, SC14-500030, SC14-500035, SC14-50040)