150372
IV
current
Occluders, Vascular, Intravascular Embolizationๅฐๅ ตๅจใ่ก็ฎกใ่ก็ฎกๅ ๆ ๅก
This profile provides complete Hong Kong MDACS registration information for Occluders, Vascular, Intravascular Embolization. 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
็ขๅ่ณ่จ๏ผ ๅฐๅ ตๅจใ่ก็ฎกใ่ก็ฎกๅ ๆ ๅก
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15034
Product Code Detail
15034 Occluders, Vascular, Intravascular Embolization
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Micro Therapeutics, Inc. DBA ev3 Neurovascular
Micro Therapeutics, Inc. Dba Ev3 Neurovascular
United States
็พๅฝ
9775 Toledo Way, Irvine, CA 92618, United States of America
9775 ๆ่ฑๅค่ทฏ, ๅฐๆนพ, CA 92618, ็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 14, 2020
Expiry Date
December 04, 2025
Product Models
Onyx-18 (105-7000-060, 105-7200-060), Onyx-20 (105-7000-065), Onyx-34 (105-7000-080, 105-7200-080), Onyx-34L (105-7315-080, 105-7360-080), Catheter Interface Adapter (103-1207)
็ผ็็-18 (105-7000-060, 105-7200-060), ็ผ็็-20 (105-7000-065), ็ผ็็-34 (105-7000-080, 105-7200-080), ็ผ็็-34L (105-7315-080, 105-7360-080), ๅฏผ็ฎกๆฅๅฃ้้
ๅจ (103-1207)