160362
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
导管、血管、血管成形术、球囊、外周动脉
OrbusNeich Medical (Shenzhen) Company Limited·II·Hong Kong MDACS·Registered October 13, 2021
Device overview
- Risk class
- II
- Product code
- 34317
- State
- current
- Status
- N/A
- Product code detail
- 34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
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
- 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 球囊扩张导管 (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)
About this record
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
產品資訊： 导管、血管、血管成形术、球囊、外周动脉