180079
IV
current
Occluders, Vascular, Intravascular Embolization, Coil封堵器,血管,血管内栓塞,线圈
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
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
current
Status
N/A
Manufacturer (製造商)
Micro Therapeutics, Inc. DBA ev3 Neurovascular
Micro Therapeutics, Inc. Dba Ev3 Neurovascular
United States
美国
9775 Toledo Way, Irvine, CA, 92618, United States of America
9775 托莱多路, 尔湾, 加利福尼亚州, 92618, 美国
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 19, 2023
Expiry Date
April 16, 2028
Product Models
Axium Helix (QC-1.5-2-HELIX, QC-2-1-HELIX, QC-2-2-HELIX, QC-2-3-HELIX, QC-2-4-HELIX, QC-2-6-HELIX, QC-2-8-HELIX, QC-3-4-HELIX, QC-3-6-HELIX, QC-1.5-1-HELIX, QC-2.5-4-HELIX, QC-3-8-HELIX, QC-4-8-HELIX, QC-4-10-HELIX, QC-4-12-HELIX, QC-5-15-HELIX, QC-5-20-HELIX, QC-6-20-HELIX, QC-7-20-HELIX, QC-7-30-HELIX, QC-1.5-3-HELIX, QC-2.5-6-HELIX, QC-8-20-HELIX, QC-8-30-HELIX, QC-9-20-HELIX, QC-9-30-HELIX, QC-10-20-HELIX, QC-10-30-HELIX, QC-12-30-HELIX, QC-12-40-HELIX, QC-14-30-HELIX, QC-1.5-4-HELIX, QC-2.5-8-HELIX, QC-14-40-HELIX, QC-16-30-HELIX, QC-16-40-HELIX, QC-18-40-HELIX, QC-20-40-HELIX, QC-20-50-HELIX, QC-2.5-2-HELIX), Axium 3D (QC-2-2-3D, QC-2-4-3D, QC-2-6-3D, QC-3-4-3D, QC-3-6-3D, QC-3-8-3D, QC-4-6-3D, QC-4-8-3D, QC-4-10-3D, QC-2.5-2-3D, QC-3-10-3D, QC-4-12-3D, QC-5-8-3D, QC-5-10-3D, QC-5-15-3D, QC-6-10-3D, QC-6-15-3D, QC-6-20-3D, QC-7-15-3D, QC-7-20-3D, QC-2.5-4-3D, QC-3.5-6-3D, QC-7-30-3D, QC-8-15-3D, QC-8-20-3D, QC-8-30-3D, QC-9-20-3D, QC-9-30-3D, QC-10-20-3D, QC-10-30-3D, QC-12-30-3D, QC-2.5-6-3D, QC-3.5-12-3D, QC-12-40-3D, QC-14-30-3D, QC-14-40-3D, QC-16-40-3D, QC-18-40-3D, QC-20-50-3D, QC-22-50-3D, QC-25-50-3D, QC-2.5-8-3D, QC-3.5-15-3D), Instant Detacher (ID-1-5), Axium PGLA Helix (PC-2-1-HELIX, PC-2-2-HELIX, PC-2-3-HELIX, PC-2-4-HELIX, PC-2-6-HELIX, PC-2-8-HELIX, PC-3-4-HELIX, PC-3-6-HELIX, PC-3-8-HELIX, PC-4-8-HELIX, PC-4-10-HELIX, PC-4-12-HELIX, PC-5-15-HELIX, PC-5-20-HELIX, PC-6-20-HELIX, PC-7-20-HELIX, PC-7-30-HELIX, PC-8-20-HELIX, PC-8-30-HELIX, PC-9-20-HELIX, PC-9-30-HELIX, PC-10-20-HELIX, PC-10-30-HELIX), Axium PGLA 3D (PC-2-2-3D, PC-2-4-3D, PC-2-6-3D, PC-3-4-3D, PC-3-6-3D, PC-3-8-3D, PC-4-6-3D, PC-4-8-3D, PC-4-10-3D, PC-4-12-3D, PC-5-8-3D, PC-5-10-3D, PC-5-15-3D, PC-6-10-3D, PC-6-15-3D, PC-6-20-3D, PC-7-15-3D, PC-7-20-3D, PC-7-30-3D, PC-8-15-3D, PC-8-20-3D, PC-8-30-3D, PC-9-20-3D, PC-9-30-3D, PC-10-20-3D, PC-10-30-3D, PC-12-30-3D, PC-12-40-3D, PC-14-30-3D, PC-14-40-3D, PC-16-40-3D, PC-18-40-3D), Nylon Helix (NC-2-1-Helix, NC-2-2-Helix, NC-2-3-Helix, NC-2-4-Helix, NC-2-6-Helix, NC-2-8-Helix, NC-3-4-Helix, NC-3-6-Helix, NC-3-8-Helix, NC-4-8-Helix, NC-4-10-Helix)
Axium Helix(QC-1.5-2-HELIX、QC-2-1-HELIX、QC-2-2-HELIX、QC-2-3-HELIX、QC-2-4-HELIX、QC-2-6-HELIX、QC-2-8-HELIX、QC-3-4-HELIX、QC-3-6-HELIX、QC-1. 5-1-HELIX、QC-2.5-4-螺旋, QC-3-8-螺旋, QC-4-8-螺旋, QC-4-10-螺旋, QC-4-12-螺旋, QC-5-15-螺旋, QC-5-20-螺旋, QC-6-20-螺旋, QC-7-20-螺旋, QC-7-30-螺旋, QC-1.5-3-螺旋, QC-2.5-6-螺旋, QC-8-20-螺旋, QC-8-30-螺旋, QC-9-20-螺旋, QC-9-30-螺旋, QC-10-20-螺旋, QC-10-30-螺旋, QC-12-30-螺旋, QC-12-40-螺旋, QC-14-30-螺旋,QC-1.5-4-螺旋、QC-2.5-8-螺旋、QC-14-40-螺旋、QC-16-30-螺旋、QC-16-40-螺旋、QC-18-40-螺旋、QC-20-40-螺旋、QC-20-50-螺旋、QC-2.5-2-螺旋)、Axium 3D(QC-2-2-3D、QC-2-4-3D、QC-2-6-3D、QC-3-4-3D、QC-3-6-3D、QC-3-8-3D、QC-4-6-3D、QC-4-8-3D、QC-4-8-3D、QC-4-10-3D、QC-2. 5-2-3D、QC-3-10-3D、QC-4-12-3D、QC-5-8-3D、QC-5-10-3D、QC-5-15-3D、QC-6-10-3D、QC-6-15-3D、QC-6-20-3D、QC-7-15-3D、QC-7-20-3D、QC-2.5-4-3D、QC-3.5-6-3D、QC-7-30-3D、QC-8-15-3D、QC-8-20-3D、QC-8-30-3D、QC-9-20-3D、QC-9-30-3D、QC-10-20-3D、QC-10-30-3D、QC-12-30-3D、QC-2.5-6-3D、QC-3.5-12-3D、QC-12-40-3D、QC-14-30-3D、QC-14-40-3D、QC-16-40-3D、QC-18-40-3D、QC-20-50-3D、QC-22-50-3D、QC-25-50-3D、QC-2. 5-8-3D、QC-3.5-15-3D)、即时分离器(ID-1-5)、Axium PGLA 螺旋(PC-2-1-HELIX、PC-2-2-2-HELIX、PC-2-3-HELIX、PC-2-4-HELIX、PC-2-6-HELIX、PC-2-8-HELIX、PC-3-4-HELIX、PC-3-6-HELIX、PC-3-8-HELIX、PC-4-8-HELIX、PC-4-10-HELIX、PC-4-12-HELIX、PC-5-15-HELIX、PC-5-20-HELIX、PC-6-20-HELIX、PC-7-20-HELIX、PC-7-30-HELIX、 PC-8-20-HELIX、PC-8-30-HELIX、PC-9-20-HELIX、PC-9-30-HELIX、PC-10-20-HELIX、PC-10-30-HELIX)、Axium PGLA 3D(PC-2-2-3D、PC-2-4-3D、PC-2-6-3D、PC-3-4-3D、PC-3-6-3D、PC-3-8-3D、PC-4-6-3D、PC-4-8-3D、PC-4-10-3D、PC-4-12-3D、PC-5-8-3D、PC-5-10-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-8-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、 PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-15-3D、PC-5-3D、PC-5-15-3D、PC-5-15-3D、PC-3D、PC-3D、PC-3D、PC-3D、 -6-10-3D、PC-6-15-3D、PC-6-20-3D、PC-7-15-3D、PC-7-20-3D、PC-7-30-3D、PC-8-15-3D、PC-8-20-3D、PC-8-30-3D、PC-9-20-3D、PC-9-30-3D、PC-10-20-3D、PC-10-30-3D、PC-12-30-3D、PC-12-40-3D、PC-14-30-3D、PC-14-40-3D、PC-16-40-3D、PC-18-40-3D)、尼龙螺旋(NC-2-1-螺旋、NC-2-2-螺旋、NC-2-3-螺旋、NC-2-4-螺旋、NC-2-6-螺旋、NC-2-8-螺旋、NC-3-4-螺旋、NC-3-6-螺旋、NC-3-8-螺旋、NC-4-8-螺旋、NC-4-10-螺旋)