110365
Stents, Vascular, Coronary, Balloon-Expandable
支架,血管支架,冠状动脉支架,球囊扩张支架
OrbusNeich Medical B.V.·IV·Hong Kong MDACS·Registered October 25, 2016
Device overview
- Risk class
- IV
- Product code
- 20422
- State
- Expired.
- Status
- N/A
- Product code detail
- 20422 Stents, Vascular, Coronary, Balloon-Expandable
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
- October 25, 2016
- Expiry date
- October 25, 2021
Product models
Azule CoCr Alloy Coronary Stent Delivery System (225-092-6A, 225-132-6A, 225-152-6A, 225-182-6A, 225-232-6A, 227-092-6A, 227-132-6A, 227-152-6A, 227-182-6A, 227-232-6A, 230-092-6A, 230-132-6A, 230-152-6A, 230-182-6A, 230-232-6A, 230-282-6A, 230-332-6A, 235-092-6A, 235-132-6A, 235-152-6A, 235-182-6A, 235-232-6A, 235-282-6A, 235-332-6A, 240-092-6A, 240-132-6A, 240-152-6A, 240-182-6A, 240-232-6A, 240-282-6A, 240-332-6A)
Azule CoCr 合金冠状动脉支架输送系统 (225-092-6A, 225-132-6A, 225-152-6A, 225-182-6A, 225-232-6A, 227-092-6A, 227-132-6A, 227-152-6A, 227-182-6A, 227-232-6A, 230-092-6A, 230-132-6A, 230-152-6A, 230-182-6A, 230-232-6A A, 230-282-6A, 230-332-6A, 235-092-6A, 235-132-6A, 235-152-6A, 235-182-6A, 235-232-6A, 235-282-6A, 235-332-6A, 240-092-6A, 240-132-6A, 240-152-6A, 240-182-6A, 240-232-6A, 240-282-6A, 240-332-6A)
About this record
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable. 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: Stents, Vascular, Coronary, Balloon-Expandable
產品資訊： 支架,血管支架,冠状动脉支架,球囊扩张支架