120601
IV
Expired.
Occluders, Vascular, Intravascular Embolization, Coilๅฐๅ ตๅจ,่ก็ฎก,่ก็ฎกๅ ๆ ๅก,็บฟๅ
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
็ขๅ่ณ่จ๏ผ ๅฐๅ ตๅจ,่ก็ฎก,่ก็ฎกๅ ๆ ๅก,็บฟๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
22543
Product Code Detail
22543 Occluders, Vascular, Intravascular Embolization, Coil
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Penumbra, Inc.
Penumbra,Inc.
United States
็พๅฝ
1351 Harbor Bay Parkway, Alameda, CA 94502, USA
1351ๆธฏๆนพๅ
ฌๅญๅคง้,้ฟๆ็ฑณ่พพ,CA 94502,็พๅฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็พ่ฐทๅป็็งๆๆ้ๅ
ฌๅธ
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)
ๅๅฝฑๆ ๅก็บฟๅ็ณป็ป (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)