180251
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
August 10, 2023
Expiry Date
August 06, 2028
Product Models
Concerto Detachable Coil System (Concerto PGLA Fiber Helix (PV-12-30-HELIX, PV-12-40-HELIX, PV-14-30-HELIX, PV-14-40-HELIX, PV-16-40-HELIX, PV-18-40-HELIX, PV-20-50-HELIX), Concerto Nylon Fiber Helix (NV-2-4-HELIX, NV-2-6-HELIX, NV-2-8-HELIX, NV-3-4-HELIX, NV-3-8-HELIX, NV-4-8-HELIX, NV-4-10-HELIX, NV-5-10-HELIX, NV-5-15-HELIX, NV-5-20-HELIX, NV-6-12-HELIX, NV-6-20-HELIX, NV-7-20-HELIX, NV-7-30-HELIX, NV-8-20-HELIX, NV-8-30-HELIX, NV-9-20-HELIX, NV-9-30-HELIX, NV-10-20-HELIX, NV-10-30-HELIX), \nConcerto PGLA Fiber 3D (PV-2-2-3D, PV-2-4-3D, PV-2-6-3D, PV-3-4-3D, PV-3-6-3D, PV-3-8-3D, PV-4-8-3D, PV-4-10-3D, PV-4-12-3D, PV-5-10-3D, PV-5-15-3D, PV-6-15-3D, PV-6-20-3D, PV-7-20-3D, PV-7-30-3D, PV-8-20-3D, PV-8-30-3D, PV-9-20-3D, PV-9-30-3D, PV-10-20-3D, PV-10-30-3D, PV-12-40-3D, PV-14-40-3D, PV-16-40-3D, PV-18-40-3D))
协奏曲可拆卸线圈系统(协奏曲 PGLA 纤维螺旋线(PV-12-30-HELIX、PV-12-40-HELIX、PV-14-30-HELIX、PV-14-40-HELIX、PV-16-40-HELIX、PV-18-40-HELIX、PV-20-50-HELIX)、协奏曲尼龙纤维螺旋线(NV-2-4-HELIX、NV-2-6-HELIX、NV-2-8-HELIX、NV-3-4-HELIX、NV-3-8-HELIX、NV-3-8-HELIX) -螺旋, NV-4-8-螺旋, NV-4-10-螺旋, NV-5-10-螺旋, NV-5-15-螺旋, NV-5-20-螺旋, NV-6-12-螺旋, NV-6-20-螺旋, NV-7-20-螺旋, NV-7-30-螺旋, NV-8-20-螺旋, NV-8-30-螺旋, NV-8-30-螺旋, NV-9-20-螺旋, NV-9-30-螺旋, NV-10-20-螺旋,NV-10-30-HELIX),\n协奏曲PGLA光纤3D(PV-2-2-3D,PV-2-4-3D,PV-2-6-3D,PV-3-4-3D,PV-3-6-3D,PV-3-8-3D,PV-4-8-3D,PV-4-10-3D,PV-4-12-3D,PV-5-10-3D,PV-5-15-3D,PV-6-15-3D,PV-6-15-3D,PV -6-20-3D, PV-7-20-3D, PV-7-30-3D, PV-8-20-3D, PV-8-30-3D, PV-9-20-3D, PV-9-30-3D, PV-10-20-3D, PV-10-30-3D, PV-12-40-3D, PV-14-40-3D, PV-16-40-3D, PV-18-40-3D))