240190
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary. 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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
State
current
Status
N/A
Brand
Scoreflex TRIO
Scoreflex ไธ้ๅฅ
Manufacturer (่ฃฝ้ ๅ)
OrbusNeich Medical (Shenzhen) Co., Ltd.
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ฌๅธ
China
ไธญๅฝ
No. 1, Jinkui Road, Futian Free Trade Zone, Shenzhen 518038, China
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Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธ่ๅป็ๆ้ๅ
ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
May 21, 2024
Expiry Date
May 20, 2029
Product Models
Scoreflex TRIO Balloon Dilatation Catheter (631751011, 631751511, 631752011, 632001011, 632001511, 632002011, 632251011, 632251511, 632252011, 632501011, 632501511, 632502011, 632751011, 632751511, 632752011, 633001011, 633001511, 633002011, 633501011, 633501511, 633502011, 634001011, 634001511, 634002011)
Scoreflex TRIO ็ๅๆฉๅผ ๅฏผ็ฎก(631751011ใ631751511ใ631752011ใ632001011ใ632001511ใ632002011ใ632251011ใ632251511ใ632252011ใ632501011ใ632501511ใ632502011ใ632751011ใ632751511ใ632752011ใ633001011ใ633001511ใ633002011ใ633501011ใ633501511ใ633502011ใ634001011ใ634001511ใ634002011)