120601
Occluders, Vascular, Intravascular Embolization, Coil
封堵器,血管,血管内栓塞,线圈
Penumbra, Inc.·IV·Hong Kong MDACS·Registered March 28, 2018
Device overview
- Risk class
- IV
- Product code
- 22543
- State
- Expired.
- Status
- N/A
- Product code detail
- 22543 Occluders, Vascular, Intravascular Embolization, Coil
Manufacturer (製造商)
- Name
- Penumbra, Inc.Penumbra,Inc.
- Country
- United States美国
- Address
- 1351 Harbor Bay Parkway, Alameda, CA 94502, USA1351港湾公园大道,阿拉米达,CA 94502,美国
Authorised representative (AR)
- Name
- Synapse Therapeutics Limited百谷医疗科技有限公司
- Phone
- 31881638
Regulatory timeline
- Registration date
- March 28, 2018
- Expiry date
- March 28, 2023
Product models
Penumbra Embolization Coil System (4002C0306, 4002C0310, 4002C0408, 4002C0412, 4002C0506, 4002C0510, 4002C0610, 4002C0615, 4002C0620, 4002C0710, 4002C0715, 4002C0720, 4002C0815, 4002C0820, 4002C0830, 4002C0915, 4002C0925, 4002C0935, 4002C1020, 4002C1030, 4002C1040, 4002C1135, 4002C1145, 4002C1235, 4002C1245, 4002C1335, 4002C1348, 4002C1440, 4002C1450, 4002C1545, 4002C1557, 4002C1645, 4002C1660, 4002C1845, 4002C1857, 4002C2045, 4002C2060, 4002C2245, 4002C2260, 4002C2448, 4002C2457, 4002C2660, 4002C2860, 4002C3060, 4002C3260, 4004C0303, 4004C0304, 4004C0306, 4004C0310, 4004C0404, 4004C0406, 4004C0408, 4004C0412, 4004C0509, 4004C0513, 4004C0610, 4004C0615, 4004C0620, 4004C0710, 4004C0715, 4004C0720, 4004C0815, 4004C0820, 4004C0830, 4004C0925, 4004C0935, 4004C1020, 4004C1030, 4004C1040, 4004C1135, 4004C1145, 4004C1235, 4004C1245, 4004C1335, 4004C1348, 4004C1440, 4004C1450, 4004C1545, 4004C1557, 4004C1645, 4004C1660, 4004C1845, 4004C1857, 4004C2045, 4004C2060, 4004C2245, 4004C2260, 4004C2448, 4004C2457, 4004J1, 4004J10, 4004J11, 4004J12, 4004J13, 4004J14, 4004J15, 4004J2, 4004J20, 4004J25, 4004J3, 4004J30, 4004J35, 4004J4, 4004J5, 4004J6, 4004J7, 4004J8, 4004J9, 4006C0201, 4006C0202, 4006C0203, 4006C0204, 4006C0302, 4006C0303, 4006C0304, 4006C0305, 4006C0306, 4006C0307, 4006C0308, 4006C0309, 4006C0310, 4006C0404, 4006C0406, 4006C0408, 4006C0410, 4006C0412, 4006C0414, 4006C0416, 4006C0418, 4006C0420, 4006U0201, 4006U0202, 4006U0203, 4006U0204, 4006U0302, 4006U0303, 4006U0304, 4006U0305, 4006U0306, 4006U0307, 4006U0308, 4006U0309, 4006U0310, 4006U0404, 4006U0406, 4006U0408, 4006U0410, 4006U0412, 4006U0414, 4006U0416, 4006U0418, 4006U0420, DH1, DH5)
半影栓塞线圈系统 (4002C0306, 4002C0310, 4002C0408, 4002C0412, 4002C0506, 4002C0510, 4002C0610, 4002C0615, 4002C0620, 4002C0710, 4002C0715, 4002C0720, 4002C0815, 4002C0820, 4002C0830, 4002C0915, 4002C0925, 4002C0935, 4002C1020, 4002C1030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C11030, 4002C0815, 4002C0820, 4002C0830, 4002C0915, 4002C0002C115 040, 4002C1135, 4002C1145, 4002C1235, 4002C1245, 4002C1335, 4002C1348, 4002C1440, 4002C1450, 4002C1545, 4002C1557, 4002C1645, 4002C1660, 4002C1845, 4002C1857, 4002C2045, 4002C2060, 4002C2245, 4002C2260, 4002C2448, 4002C2457, 4002C2660, 4002C2860, 4002C3060, 4002C3260, 4004C0303, 4004C0304, 4004C0306, 4004C0310, 4004C0404, 4004C0406, 4004C0408, 4004C0412, 4004C0509, 4004C0513, 4004C0610, 4004C0615, 4004C0620, 4004C0710, 4004C0715, 4004C0720, 4004C0815, 4004C0820, 4004C0830, 4004C083 0 925, 4004C0935, 4004C1020, 4004C1030, 4004C1040, 4004C1135, 4004C1145, 4004C1235, 4004C1245, 4004C1335, 4004C1348, 4004C1440, 4004C1450, 4004C1545, 4004C1557, 4004C1645, 4004C1660, 4004C1845, 4004C1857, 4004C2045, 4004C2060, 4004C2245, 4004C2260, 4004C2448, 4004C2457, 4004J1, 4004J10, 4004J11, 4004J12, 4004J13, 4004J14, 4004J15, 4004J2, 4004J20, 4004J25, 4004J3, 4004J30, 4004J35, 4004J4, 4004J5, 4004J6, 4004J7, 4004J8, 4004J9, 4006C0201, 4006C0202, 4006C0203, 4006C0204, 4006C0302, 4006C0302 , 4006C0304, 4006C0305, 4006C0306, 4006C0307, 4006C0308, 4006C0309, 4006C0310, 4006C0404, 4006C0406, 4006C0408, 4006C0410, 4006C0412, 4006C0414, 4006C0416, 4006C0418, 4006C0420, 4006U0201, 4006U0202, 4006U0203, 4006U0204, 4006U0302, 4006U0303, 4006U0304, 4006U0305, 4006U0306, 4006U0307, 4006U0308, 4006U0309, 4006U0310, 4006U0404, 4006U0406, 4006U0408, 4006U0410, 4006U0412, 4006U0414, 4006U0418, 4006U0420, DH1, DH5)
About this record
This profile provides complete Hong Kong MDACS registration information for Occluders, Vascular, Intravascular Embolization, Coil. 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: Occluders, Vascular, Intravascular Embolization, Coil
產品資訊： 封堵器,血管,血管内栓塞,线圈