Medical Device Division · registration 120601ExpiredPenumbra
Hong KongOccluders, Vascular, Intravascular Embolization, CoilClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 120601
- Model name
- 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)
- Registration date
- March 28, 2018
- Expiry date
- March 28, 2023
- Source update date
- June 10, 2021
- Status
- Expired
Classification
- Risk class
- Class IV
- Published category
- Occluders, Vascular, Intravascular Embolization, Coil
Official value: IV
Published parties
- Registrant / registration holder
- Synapse Therapeutics Limited
- Manufacturer
- Penumbra, Inc.
Official description
Occluders, Vascular, Intravascular Embolization, Coil
Additional source fields
- AMD nomenclature code
- 22543
- Traditional Chinese local responsible person
- 百谷醫療科技有限公司
- Local responsible person phone
- 31881638
- Published manufacturer address
- 1351 Harbor Bay Parkway, Alameda, CA 94502, USA
- Published remarks
- Expired.
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.