180507
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架
OrbusNeich Medical B.V.·IV·Hong Kong MDACS·Registered November 27, 2023
Device overview
- Risk class
- IV
- Product code
- 20383
- State
- current
- Status
- N/A
- Product code detail
- 20383 Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
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
- November 27, 2023
- Expiry date
- December 06, 2028
Product models
COMBO Plus Dual Therapy Stent (COMBO Plus Stent) (225-092-11 , 225-132-11 , 225-152-11 , 225-182-11 , 225-232-11 , 225-282-11 , 225-332-11 , 227-092-11 , 227-132-11 , 227-152-11 , 227-182-11 , 227-232-11 , 227-282-11 , 227-332-11 , 230-092-11 , 230-132-11 , 230-152-11 , 230-182-11 , 230-232-11 , 230-282-11 , 230-332-11 , 230-382-11 , 235-092-11 , 235-132-11 , 235-152-11 , 235-182-11 , 235-232-11 , 235-282-11 , 235-332-11 , 235-382-11 , 240-092-11 , 240-132-11 , 240-152-11 , 240-182-11 , 240-232-11 , 240-282-11 , 240-332-11 , 240-382-11)
COMBO 加双联治疗支架 (COMBO 加支架) (225-092-11 , 225-132-11 , 225-152-11 , 225-182-11 , 225-232-11 , 225-282-11 , 225-332-11 , 227-092-11 , 227-132-11 , 227-152-11 , 227-182-11 , 227-232-11 , 227-282-11 , 227-332-11 , 230-092-11 , 230-132-11 , 2300 -152-11 , 230-182-11 , 230-232-11 , 230-282-11 , 230-332-11 , 230-382-11 , 235-092-11 , 235-132-11 , 235-152-11 , 235-182-11 , 235-232-11 , 235-282-11 , 235-332-11 , 235-382-11 , 240-092-11 , 240-132-11 , 240-152-11 , 240-182-11 , 240-232-11 , 240-282-11 , 240-332-11 , 240-382-11)
About this record
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting. 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, Drug-Eluting
產品資訊： 血管支架、冠状动脉支架、球囊扩张支架、药物洗脱支架