110054
IV
current
Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon. 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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
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
April 12, 2021
Expiry Date
April 12, 2026
Product Models
Sapphire II (Rx) Coronary Dilatation Catheter (234-RL-1005J, 234-RL-1008J, 234-RL-1010J, 234-RL-1015J, 234-RL-1205J, 234-RL-1208J, 234-RL-1210J, 234-RL-1215J, 234-RL-1510J, 234-RL-1515J, 234-RL-1520J, 234-RL-1710J, 234-RL-1715J, 234-RL-1720J, 234-RL-2010J, 234-RL-2015J, 234-RL-2020J, 234-R-1005J, 234-R-1008J, 234-R-1010J, 234-R-1015J, 234-R-1205J, 234-R-1208J, 234-R-1210J, 234-R-1215J, 234-R-1510J, 234-R-1512J, 234-R-1515J, 234-R-1520J, 234-R-1710J, 234-R-1715J, 234-R-1720J, 234-R-2010J, 234-R-2012J, 234-R-2015J, 234-R-2020J, 234-R-2210J, 234-R-2215J, 234-R-2220J, 234-R-2510J, 234-R-2512J, 234-R-2515J, 234-R-2520J, 234-R-2530J, 234-R-2710J, 234-R-2715J, 234-R-2720J, 234-R-3010J, 234-R-3012J, 234-R-3015J, 234-R-3020J, 234-R-3030J, 234-R-3210J, 234-R-3215J, 234-R-3220J, 234-R-3510J, 234-R-3515J, 234-R-3520J, 234-R-3530J, 234-R-4010J, 234-R-4015J, 234-R-4020J)
่ๅฎ็ณ II (Rx) ๅ ็ถๅจ่ๆฉๅผ ๅฏผ็ฎก (234-RL-1005J, 234-RL-1008J, 234-RL-1010J, 234-RL-1015J, 234-RL-1205J, 234-RL-1208J, 234-RL-1210J, 234-RL-1215J, 234-RL-1510J, 234-RL-1515J, 234-RL-1520J, 234-RL-1710J, 234-RL-1715J, 234-RL-1720J, 234-RL-2010J, 234-RL-2015J, 234-RL-2020J, 234-R-1005J, 234-R-1008J, 234-R-1010J, 234-R-1015J, 234-R-1205J, 234-R-1208J, 234-R-1210J, 234-R-1215J, 234-R-1510J, 234-R-1512J, 234-R-1515J, 234-R-1520J, 234-R-1710J, 234-R-1715J, 234-R-1720J, 234-R-2010J, 234-R-2012J, 234-R-2015J, 234-R-2020J, 234-R-2210J, 234-R-2215J, 234-R-2220J, 234-R-2220J, 234-R-2220J 34-R-2510J, 234-R-2512J, 234-R-2515J, 234-R-2520J, 234-R-2530J, 234-R-2710J, 234-R-2715J, 234-R-2720J, 234-R-3010J, 234-R-3012J, 234-R-3015J, 234-R-3020J, 234-R-3030J, 234-R-3210J, 234-R-3215J, 234-R-3220J, 234-R-3510J, 234-R-3515J, 234-R-3520J, 234-R-3530J, 234-R-4010J, 234-R-4015J, 234-R-4020J)