180439
Catheters, Vascular, Angioplasty, Balloon, Coronary
导管、血管、血管成形术、球囊、冠状动脉
OrbusNeich Medical B.V.·IV·Hong Kong MDACS·Registered August 29, 2023
Device overview
- Risk class
- IV
- Product code
- 34313
- State
- current
- Status
- N/A
- Product code detail
- 34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
Manufacturer (製造商)
- Name
- OrbusNeich Medical B.V.Orbusneich Medical, B.V.
- Country
- Netherlands荷兰
- Address
- Drs. W. van Royenstraat 5, 3871 AN Hoevelaken, The NetherlandsDrs. W. van Royenstraat 5, 3871 AN Hoevelaken, 荷兰
Authorised representative (AR)
- Name
- OrbusNeich Medical Company Limited业聚医疗有限公司
- Phone
- 31097271/31097216
Regulatory timeline
- Registration date
- August 29, 2023
- Expiry date
- November 09, 2028
Product models
Scoreflex NC Coronary Dilatation Catheter (617-104-1 , 617-154-1 , 617-204-1 , 620-104-1 , 620-154-1 , 620-204-1 , 622-104-1 , 622-154-1 , 622-204-1 , 625-104-1 , 625-154-1 , 625-204-1 , 627-104-1 , 627-154-1 , 627-204-1 , 630-104-1 , 630-154-1 , 630-204-1 , 635-104-1 , 635-154-1 , 635-204-1 , 640-104-1 , 640-154-1 , 640-204-1)
Scoreflex NC 冠状动脉扩张导管 (617-104-1 , 617-154-1 , 617-204-1 , 620-104-1 , 620-154-1 , 620-204-1 , 622-104-1 , 622-154-1 , 622-204-1 , 625-104-1 , 625-154-1 , 625 -204-1 , 627-104-1 , 627-154-1 , 627-204-1 , 630-104-1 , 630-154-1 , 630-204-1 , 635-104-1 , 635-154-1 , 635-204-1 , 640-104-1 , 640-154-1 , 640-204-1)
About this record
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
產品資訊： 导管、血管、血管成形术、球囊、冠状动脉