160362
II
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Arteryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery. 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, Peripheral Artery
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34317
Product Code Detail
34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
OrbusNeich Medical (Shenzhen) Company Limited
ไธ่ๅป็ๅจๆขฐ๏ผๆทฑๅณ๏ผๆ้ๅ
ฌๅธ
China
ไธญๅฝ
No. 1, Jinkui Road, Futian Free Trade Zone, Shenzhen 518038, China
็ฆ็ฐไฟ็จๅบ้ๅฅ่ทฏ1ๅท, ๆทฑๅณ518038, ไธญๅฝ
Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธ่ๅป็ๆ้ๅ
ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
October 13, 2021
Expiry Date
October 13, 2026
Product Models
Scoreflex PTA Balloon Dilatation Catheter (AS640-204C, AS640-404C, AS650-204C, AS650-404C, AS660-204C, AS660-404C, AM620-204C, AM620-404C, AM625-204C, AM625-404C, AM630-204C, AM630-404C, AM635-204C, AM635-404C, AM640-204C, AM640-404C, AM645-204C, AM645-404C, AM650-204C, AM650-404C, AM655-204C, AM655-404C, AM660-204C, AM660-404C, AL620-154C, AL620-204C, AL620-404C, AL625-154C, AL625-204C, AL625-404C, AL630-154C, AL630-204C, AL630-404C, AL635-154C, AL635-204C, AL635-404C, AL640-154C, AL640-204C, AL640-404C, AL645-154C, AL645-204C, AL645-404C, AL650-154C, AL650-204C, AL650-404C, AL655-154C, AL655-204C, AL655-404C, AL660-154C, AL660-204C, AL660-404C, AL620-154N, AL620-204N, AL620-404N, AL625-154N, AL625-204N, AL625-404N, AL630-154N, AL630-204N, AL630-404N, AL635-154N, AL635-204N, AL635-404N, AL640-154N, AL640-204N, AL640-404N, BS640-204C, BS640-404C, BS650-204C, BS650-404C, BS660-204C, BS660-404C, BM620-204C, BM620-404C, BM625-204C, BM625-404C, BM630-204C, BM630-404C, BM635-204C, BM635-404C, BM640-204C, BM640-404C, BM645-204C, BM645-404C, BM650-204C, BM650-404C, BM655-204C, BM655-404C, BM660-204C, BM660-404C, BL620-154C, BL620-204C, BL620-404C, BL625-154C, BL625-204C, BL625-404C, BL630-154C, BL630-204C, BL630-404C, BL635-154C, BL635-204C, BL635-404C, BL640-154C, BL640-204C, BL640-404C, BL645-154C, BL645-204C, BL645-404C, BL650-154C, BL650-204C, BL650-404C, BL655-154C, BL655-204C, BL655-404C, BL660-154C, BL660-204C, BL660-404C)
Scoreflex PTA ็ๅๆฉๅผ ๅฏผ็ฎก (AS640-204C, AS640-404C, AS650-204C, AS650-404C, AS660-204C, AS660-404C, AM620-204C, AM620-404C, AM625-204C, AM625-404C, AM630-204C, AM630-404C, AM635-204C, AM635-404C, AM640-204C, AM640-404C, AM645-204C, AM645-404C C, AM650-204C, AM650-404C, AM655-204C, AM655-404C, AM660-204C, AM660-404C, AL620-154C, AL620-204C, AL620-404C, AL625-154C, AL625-204C, AL625-404C, AL630-154C, AL630-204C, AL630-404C, AL635-154C, AL635-204C, AL635-404C, AL640-154C,AL640-204C, AL640-404C, AL645-154C, AL645-204C, AL645-404C, AL650-154C, AL650-204C, AL650-404C, AL655-154C, AL655-204C, AL655-404C, AL660-154C, AL660-204C, AL660-404C, AL620-154N, AL620-204N, AL620-404N, AL625-154N, AL625-204N, AL625-404N, AL630-154N, AL630-204N, AL630-404N, AL635-154N, AL635-204N, AL635-404N, AL640-154N, AL640-204N, AL640-404N, BS640-204C, BS640-404C, BS650-204C, BS650-404C, BS660-204C, BS660-404C, BM620-204C, BM620-404C, BM625-204C, BM625-404C, BM630-204C, BM630-404C, BM635-204C, BM635-404C, BM640-204C, BM640-404C, BM645-204C, BM645-404C, BM650-204C, BM650-404C, BM655-204C, BM655-404C, BM660-204C, BM660-404C, BL620-154C, BL620-204C, BL620-404C, BL625-154C, BL625-204C, BL625-404C, BL630-154C, BL630-204C, BL630-204C, BL630-204C, BL630-204C l630-404C, BL635-154C, BL635-204C, BL635-404C, BL640-154C, BL640-204C, BL640-404C, BL645-154C, BL645-204C, BL645-404C, BL650-154C, BL650-204C, BL650-404C, BL655-154C, BL655-204C, BL655-404C, BL660-154C, BL660-204C, BL660-404C)