Pure Global
160417
IV
current

Occluders, Vascular, Intravascular Embolizationๅฐๅ ตๅ™จใ€่ก€็ฎกใ€่ก€็ฎกๅ†…ๆ “ๅกž

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

็”ขๅ“่ณ‡่จŠ๏ผš ๅฐๅ ตๅ™จใ€่ก€็ฎกใ€่ก€็ฎกๅ†…ๆ “ๅกž

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
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Micro Therapeutics, Inc. DBA ev3 Neurovascular
Micro Therapeutics, Inc. Dba Ev3 Neurovascular
United States
็พŽๅ›ฝ
9775 Toledo Way, Irvine, CA, 92618, United States of America
9775 ๆ‰˜่Žฑๅคš่ทฏ, ๅฐ”ๆนพ, ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž, 92618, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
November 11, 2021
Expiry Date
December 05, 2026
Product Models
Axium Prime Detachable Coil System (APB-4-6-HX-SS, APB-4-8-HX-SS, APB-4-10-HX-SS, APB-4-12-HX-SS, APB-5-10-HX-SS, APB-5-15-HX-SS, APB-5-20-HX-SS, APB-6-12-HX-SS, APB-6-20-HX-SS, APB-1-1-HX-ES, APB-1-2-HX-ES, APB-1-3-HX-ES, APB-1.5-1-HX-ES, APB-1.5-2-HX-ES, APB-1.5-3-HX-ES, APB-1.5-4-HX-ES, APB-2-1-HX-ES, APB-2-2-HX-ES, APB-2-3-HX-ES, APB-2-4-HX-ES, APB-2-6-HX-ES, APB-2-8-HX-ES, APB-2.5-3-HX-ES, APB-2.5-4-HX-ES, APB-2.5-6-HX-ES, APB-2.5-8-HX-ES, APB-3-4-HX-ES, APB-3-6-HX-ES, APB-3-8-HX-ES, APB-3-10-HX-ES, APB-4-6-3D-SS, APB-4-8-3D-SS, APB-4-10-3D-SS, APB-4-12-3D-SS, APB-5-8-3D-SS, APB-5-10-3D-SS, APB-5-15-3D-SS, APB-6-10-3D-SS, APB-6-15-3D-SS, APB-6-20-3D-SS, APB-1-2-3D-ES, APB-1-3-3D-ES, APB-1-4-3D-ES, APB-1.5-2-3D-ES, APB-1.5-3-3D-ES, APB-1.5-4-3D-ES, APB-2-2-3D-ES, APB-2-3-3D-ES, APB-2-4-3D-ES, APB-2.5-4-3D-ES, APB-2.5-6-3D-ES, APB-3-4-3D-ES, APB-3-6-3D-ES, APB-3-8-3D-ES, APB-3.5-6-3D-ES, APB-3.5-8-3D-ES, APB-3.5-10-3D-ES, FC-3-6-3D, FC-3-8-3D, FC-3-10-3D, FC-3.5-6-3D, FC-3.5-8-3D, FC-3.5-10-3D, FC-4-6-3D, FC-4-8-3D, FC-4-10-3D, FC4-12-3D, FC-4-15-3D, FC-5-8-3D, FC-5-10-3D, FC-5-15-3D, FC-5-20-3D, FC-6-10-3D, FC-6-15-3D, FC-6-20-3D, FC-6-25-3D, FC-7-12-3D, FC-7-15-3D, FC-7-20-3D, FC-7-30-3D, FC-8-15-3D, FC-8-20-3D, FC-8-30-3D, FC-9-20-3D, FC-9-30-3D, FC-10-20-3D, FC-10-30-3D, FC-10-40-3D, FC-12-30-3D, FC-12-40-3D, FC-12-50-3D, FC-14-30-3D, FC-14-40-3D, FC-14-50-3D, FC-16-40-3D, FC-16-50-3D, FC-18-40-3D, FC-18-50-3D, FC-20-50-3D, FC-22-50-3D, FC-25-50-3D)
Axium Prime Detachable Coil System (APB-4-6-HX-SSS, APB-4-8-HX-SSS, APB-4-10-HX-SS, APB-4-12-HX-SS, APB-5-10-HX-SS, APB-5-15-HX-SS, APB-5-20-HX-SS, APB-6-12-HX-SS, APB-6-20-20-HX-SS, APB-1-1-HX-ES, APB-1-2-2-HX-ES, APB-1-3-HX-ES, APB-1.5-1-HX-ES, APB-1.5-2-HX-ES, APB-1.5-3-HX-ES, APB-1.5-4-HX-ES, APB-2-1-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-4-HX-ES, APB-2-6-HX-ES, APB-2-8-HX-ES, APB-2.5-3-HX-ES, APB-2.5-4-HX-ES, APB-2.5-6-HX-ES, APB-2.5-8-HX-ES, APB-3-4-HX-ES, APB-3-6-HX-ES, APB-3-3-HX-ES, APB-2.5-6-HX-ES, APB-2.5-6-HX-ES, APB-2.5-8-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-2-2-HX-ES, APB-APB-3-8-8-HX-ES, APB-3-10-HX-ES, APB-4-6-3D-SS, APB-4-8-3D-SS, APB-4-10-3D-SS, APB-4-12-3D-SS, APB-5-8-3D-SS, APB-5-10-3D-SS, APB-5-15-3D-SS, APB-6-10-3D-SS, APB-6-15-3D-SS, APB-6-20-3D-SS, APB-1-2-2-3D-ES, APB-1-3-3D-ES, APB-1-3-3D-ES, APB-1-3D-ES, APB-1-3D-ES, APB-1-3D-ES, APB-1-3D-SS, APB-1-3D-SS, APB-1-3D-SS, APB-1-3D-SS, APB-1-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-15-3D-SS, APB-6-10-3D-SS, APB-6-10-3D-SS, APB-6-10-3D-SS, APB-6-10-3D-SS, APB-10-3D-SS, APB-10-3D-SS, APB-5-10-3D-SS, APB-4-10-3D-SS, APB-5-10-3D-SS, APB-5-10-3D-SS, APB-4-10-3D-SS, APB-45-2-3D-ES, APB-1.5-3-3D-ES, APB-1.5-4-3D-ES, APB-2-2-3D-ES, APB-2-3D-ES, APB-2-4-3D-ES, APB-2.5-4-3D-ES, APB-2.5-6-3D-ES, APB-3-4-3D-ES, APB-3-6-3D-ES, APB-3-8-3D-ES, APB-3-3D-ES, APB-3.5-8-3D-ES, APB-3.5-10-3D-ES, FC-3-6-3D, FC-3-8-3D-ES, FC-3-6-3D, FC-3-8-3D-ES, APB-3-8-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3D-ES, APB-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3-3D-ES, APB-3D-ES, APB-3-3D-ES, APB-3D-ES, APB-3D-ES, APB-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-2-3D-ES, APB-, FC-3-10-3D, FC-3.5-6-3D, FC-3.3D, FC-3.3D, FC-3.5-10-3D, FC-3.5-6-3D, FC-3.5-6-3D, FC-3.5-6-3D5-8-3D, FC-3.5-10-3D, FC-4-6-3D, FC-4-8-3D, FC-4-8-3D, FC-4-10-10-3D, FC-4-12-3D, FC-4-15-15-3D, FC-5-10-3D, FC-5-10-3D, FC-5-10-10-3D, FC-6-10-10-3D, FC-6-15-3D, FC-6-20-20-3D, FC-6-25-3D, FC-7-12-3D, FC-7-15-15-3D, FC-7-20-3D, FC-7-20-3D, FC-8-15-3D, FC-8-15-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, FC-8-20-3D, -3D, FC-9-20-3D, FC-9-20-3D, FC-9-30-3D, FC-10-20-3D, FC-10-30-3D, FC-10-40-3D, FC-12-40-3D, FC-12-40-3D, FC-14-30-3D, FC-14-40-3D, FC-14-40-3D, FC-14-50-3D, FC-16-40-3D, FC-16-50-3D, FC-16-50-3D, FC-18-40-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-50-3D, FC-18-FC-20-50-3D, FC-22-50-3D, FC-25-50-3D)