110054
Catheters, Vascular, Angioplasty, Balloon
导管、血管、血管成形术、球囊
OrbusNeich Medical (Shenzhen) Company Limited·IV·Hong Kong MDACS·Registered April 12, 2021
Device overview
- Risk class
- IV
- Product code
- 17184
- State
- current
- Status
- N/A
- Product code detail
- 17184 Catheters, Vascular, Angioplasty, Balloon
Manufacturer (製造商)
- Name
- OrbusNeich Medical (Shenzhen) Company Limited业聚医疗器械（深圳）有限公司
- Country
- China中国
- Address
- No.1 Jinkui Road, Futian Free Trade Zone, Shenzhen 518038, China福田保税区金奎路1号, 深圳518038, 中国
Authorised representative (AR)
- Name
- OrbusNeich Medical Company Limited业聚医疗有限公司
- Phone
- 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)
蓝宝石 II (Rx) 冠状动脉扩张导管 (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)
About this record
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
產品資訊： 导管、血管、血管成形术、球囊