140105

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 March 01, 2019
Device overview
Risk class
IV
Product code
20383
State
Expired.
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 Netherlands
Drs 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
March 01, 2019
Expiry date
April 07, 2024
Product models
Combo Bio-Engineered Sirolimus Eluting Stent (225-092-8, 225-132-8, 225-152-8, 225-182-8, 225-232-8, 227-092-8, 227-132-8, 227-152-8, 227-182-8, 227-232-8, 230-092-8, 230-132-8, 230-152-8, 230-182-8, 230-232-8, 230-282-8, 230-332-8, 235-092-8, 235-132-8, 235-152-8, 235-182-8, 235-232-8, 235-282-8, 235-332-8, 240-092-8, 240-132-8, 240-152-8, 240-182-8, 240-232-8, 240-282-8, 240-332-8, 225-282-8, 225-332-8, 227-282-8, 227-332-8, 230-382-8, 235-382-8, 240-382-8)
组合生物工程西罗莫司洗脱支架(225-092-8, 225-132-8, 225-152-8, 225-182-8, 225-232-8, 227-092-8, 227-132-8, 227-152-8, 227-182-8, 227-232-8, 230-092-8, 230-132-8, 230-152-8, 230-182-8, 230-232-8, 230-282-8, 230-332-8, 235-092-8, 235 -132-8, 235-152-8, 235-182-8, 235-232-8, 235-282-8, 235-332-8, 240-092-8, 240-132-8, 240-152-8, 240-182-8, 240-232-8, 240-282-8, 240-332-8, 225-282-8, 225-332-8, 227-282-8, 227-332-8, 230-382-8, 235-382-8, 240-382-8)
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