Pure Global
160203
IV
current

Stents, Vascular, Intracranial Artery, Aneurysm Bifurcationๆ”ฏๆžถใ€่ก€็ฎกใ€้ข…ๅ†…ๅŠจ่„‰ใ€ๅŠจ่„‰็˜คๅˆ†ๅ‰

This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Intracranial Artery, Aneurysm Bifurcation. 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: Stents, Vascular, Intracranial Artery, Aneurysm Bifurcation

็”ขๅ“่ณ‡่จŠ๏ผš ๆ”ฏๆžถใ€่ก€็ฎกใ€้ข…ๅ†…ๅŠจ่„‰ใ€ๅŠจ่„‰็˜คๅˆ†ๅ‰

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
28494
Product Code Detail
28494 Stents, Vascular, Intracranial Artery, Aneurysm Bifurcation
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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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, CA 92618, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 03, 2021
Expiry Date
June 21, 2026
Product Models
Pipeline Flex Embolization Device (PED-250-10, PED-250-12, PED-250-14, PED-250-16, PED-250-18, PED-250-20, PED-275-10, PED-275-12, PED-275-14, PED-275-16, PED-275-18, PED-275-20, PED-300-10, PED-300-12, PED-300-14, PED-300-16, PED-300-18, PED-300-20, PED-300-25, PED-300-30, PED-300-35, PED-325-10, PED-325-12, PED-325-14, PED-325-16, PED-325-18, PED-325-20, PED-325-25, PED-325-30, PED-325-35, PED-350-10, PED-350-12, PED-350-14, PED-350-16, PED-350-18, PED-350-20, PED-350-25, PED-350-30, PED-350-35, PED-375-10, PED-375-12, PED-375-14, PED-375-16, PED-375-18, PED-375-20, PED-375-25, PED-375-30, PED-375-35, PED-400-10, PED-400-12, PED-400-14, PED-400-16, PED-400-18, PED-400-20, PED-400-25, PED-400-30, PED-400-35, PED-425-10, PED-425-12, PED-425-14, PED-425-16, PED-425-18, PED-425-20, PED-425-25, PED-425-30, PED-425-35, PED-450-10, PED-450-12, PED-450-14, PED-450-16, PED-450-18, PED-450-20, PED-450-25, PED-450-30, PED-450-35, PED-475-10, PED-475-12, PED-475-14, PED-475-16, PED-475-18, PED-475-20, PED-475-25, PED-475-30, PED-475-35, PED-500-10, PED-500-12, PED-500-14, PED-500-16, PED-500-18, PED-500-20, PED-500-25, PED-500-30, PED-500-35, PED2-250-10, PED2-250-12, PED2-250-14, PED2-250-16, PED2-250-18, PED2-250-20, PED2-275-10, PED2-275-12, PED2-275-14, PED2-275-16, PED2-275-18, PED2-275-20, PED2-300-10, PED2-300-12, PED2-300-14, PED2-300-16, PED2-300-18, PED2-300-20, PED2-300-25, PED2-300-30, PED2-300-35, PED2-325-10, PED2-325-12, PED2-325-14, PED2-325-16, PED2-325-18, PED2-325-20, PED2-325-25, PED2-325-30, PED2-325-35, PED2-350-10, PED2-350-12, PED2-350-14, PED2-350-16, PED2-350-18, PED2-350-20, PED2-350-25, PED2-350-30, PED2-350-35, PED2-375-10, PED2-375-12, PED2-375-14, PED2-375-16, PED2-375-18, PED2-375-20, PED2-375-25, PED2-375-30, PED2-375-35, PED2-400-10, PED2-400-12, PED2-400-14, PED2-400-16, PED2-400-18, PED2-400-20, PED2-400-25, PED2-400-30, PED2-400-35, PED2-425-10, PED2-425-12, PED2-425-14, PED2-425-16, PED2-425-18, PED2-425-20, PED2-425-25, PED2-425-30, PED2-425-35, PED2-450-10, PED2-450-12, PED2-450-14, PED2-450-16, PED2-450-18, PED2-450-20, PED2-450-25, PED2-450-30, PED2-450-35, PED2-475-10, PED2-475-12, PED2-475-14, PED2-475-16, PED2-475-18, PED2-475-20, PED2-475-25, PED2-475-30, PED2-475-35, PED2-500-10, PED2-500-12, PED2-500-14, PED2-500-16, PED2-500-18, PED2-500-20, PED2-500-25, PED2-500-30, PED2-500-35)
Pipeline Flex Embolization Device (PED-250-10, PED-250-12, PED-250-14, PED-250-16, PED-250-18, PED-250-20, PED-275-10, PED-275-12, PED-250-12, PED-250-20, PED-250-20, PED-275-10, PED-275-12, PED-250-12, PED-250-12, PED-250-20, PED-250-20, PED-275-10, PED-275-12, PED-250-12. PED-275-14, PED-275-16, PED-275-18, PED-275-20, PED-300-10, PED-300-12, PED-300-14, PED-300-16, PED-300-18, PED-300-20, PED-300-25, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-10, PED-300-20, PED-300-20, PED-300-30, PED-300-30, PED-300-10, PED-300-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-30, PED-300-PED-300-35, PED-325-10, PED-325-12, PED-325-14, PED-325-16, PED-325-18, PED-325-20, PED-325-25,325-30, PED-325-30, PED-325-30, PED-325-30, PED-325-30, PED-325-30, PED-325-30, PED-325-30, PED-325-10, PED-325-12, PED-325-12, PED-325-14, PED-325-16, PED-325-18, PED-325-20, PED-325-12, PED-325-325-30, PED-325-14, PED-325-10, PED-ED-325-35, PED-350-10, PED-350-12, PED-350-14, PED-350-16, PED-350-18, PED-350-20, PED-350-25, PED-350-30, PED-350-30, PED-350-30, PED-350-20, PED-350-30, PED-350-30, PED-350-30, PED-350-30, PED-350-10, PED-350-20, PED-350-12, PED-350-30, PED-350-10, PED-350-10, PED-350-20, PED-350-12, PED-350-30, PED-350-10, PED-350-10, PED-350-35, PED-375-10, PED-375-12, PED-375-14, PED-375-16, PED-375-18, PED-375-20, PED-375-25-25, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-30, PED-375-12, PED-375-30, PED-375-30, PED-375-30, PED-375-10, PED-375-10, PED-375-30, PED-375-30, PED-375-10, PED-375-1 PED-375-35, PED-400-10, PED-400-12, PED-400-14, PED-400-16, PED-400-18, PED-400-20, PED-400-25, PED-400-30, PED-400-35, PED-425-10, PED-425-12, PED-425-12, PED-400-30, PED-400-35, PED-425-10, PED-425-12, PED-400-12, PED-400-30, PED-400-16, PED-400-10, PED-400-10, PED-400-12, PED-400-14, PED-400-16, PED-400-16, PED-400-10, PED-400-12, PED-400-14, PED-400-10, PED-400-16, PED-400-10, PED-400-10, PED-400-12, PED-400-25, PED-400-12, PED PED-425-14, PED-425-16, PED-425-18, PED-425-20, PED-425-25, PED-425-30, PED-425-35, PED-450-10, PED-450-12, PED-450-14, PED-450-14, PED-4250-14, PED-450-14, PED-450-14, PED-450-14, PED-450-14, PED-425-14, PED-425-14, PED-425-10, PED-425-14, PED-425-14, PED-425-14, PED-425-10, PED-450-12, PED-450-14, PED-450-14, PED-425-14, PED-425-14, PED-425-10, PED-450-10, PED-ED-450-16, PED-450-18, PED-450-20, PED-450-25, PED-450-30, PED-450-35, PED-475-10, PED-475-12, PED-475-14, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-475-16, PED-450-14. PED-475-18, PED-475-20, PED-475-25, PED-475-30, PED-475-35, PED-500-10, PED-500-12, PED-500-14, PED-500-16, PED-500-16, PED-500-16, PED-500-14, PED-500-16, PED-500-16, PED-500-16, PED-500-16, PED-500-14, PED-500-14, PED-500-16, PED-500-14, PED-500-16, PED-500-14, PED-500-14, PED-500-16, PED-500-16, PED-500-14, PED-500-14, PED PED-500-18, PED-500-20, PED-500-25, PED-500-30, PED2-250-10, PED2-250-12, PED2-250-14, PED2-250-14, PED2-250-16, PED2-250-18, PED2-250-20, PED2-250-20, PED2-250-20, PED2-250-20, PED2-250-20, PED2-250-2014, PED2-250-14, PED2-500-16, PED2-250-10, PED2-250-10, PED2-250-12, PED2-250-14, PED2-250-16, PED2-250-18, PED2-250-20-200-200-200-200-2014, PED2-250-14, PED2-500-14, PED2-500-19, PED2-250-10, PED2-250-14, PED PED2-275-10, PED2-275-12, PED2-275-14, PED2-275-16, PED2-275-18, PED2-275-20, PED2-300-10, PED2-300-12, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-10, PED2-300-14, PED2-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-16, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PED2-300-14, PEDED2-300-16, PED2-300-18, PED2-300-20, PED2-300-25, PED2-300-30, PED2-300-35, PED2-325-10, PED2-325-12, PED2-325-14, PED2-325-14PED2-325-16, PED2-325-18, PED2-325-20, PED2-325-25, PED2-325-30, PED2-325-35, PED2-350-10, PED2-350-12, PED2-350-12, PED2-350-12, PED2-350-12, PED2-350-12, PED2-350-12, PED2-350-12, PED2-350-12, PED2-325-35, PED2-350-10, PED2-350-12, PED2-350-12, PED2-325-35, PED2-350-10, PED2-350-12, PED2-350-12, PED2-325-35, PED PED2-350-14, PED2-350-16, PED2-350-18, PED2-350-20, PED2-350-25, PED2-350-30, PED2-350-35, PED2-375-10, PED2-375-12, PED2-375-14, PED2-375-16, PED2-375-16, PED2-375-16, PED2-375-16, PED2-375-16, PED2-375-16, PED2-350-18, PED2-350-10, PED2-350-14, PED2-350-30, PED2-350-18, PED2-350-10, PED2-350-10, PED2-350-30, PED2-350-18, PED2-350-10, PED2-350-18, PED2-350-18, PED2-350-14, PED2-350-30, PED2-350-35, PED2-375,PED2-375-10, PED2-3 PED2-375-18, PED2-375-20, PED2-375-25, PED2-375-30, PED2-375-35, PED2-400-10, PED2-400-12, PED2-400-14, PED2-400-16, PED2-400-16, PED2-400-12, PED2-400-14, PED2-400-16, PED2-400-16, PED2-400-16, PED2-400-14, PED2-400-12, PED2-400-14, PED2-375-16, PED2-400-10, PED2-400-12, PED2-400-14, PED2-400-16, PED2-400-14, PED2-400-14, PED2-400-14, PED2-400-12, PED2-ED2-400-18, PED2-400-20, PED2-400-25, PED2-400-30, PED2-400-35, PED2-425-10, PED2-425-12, PED2-425-14, PED2-425-16, PED2-425-16, PED2-425-10, PED2-425-14, PED2-425-14, PED2-425-16, PED2-425-16, PED2-425-10, PED2-425-12, PED2-425-14, PED2-425-10, PED2-425-10, PED2-425-12, PED2-425-14, PED2-425-14, PED2-425-10, PED2-425-10, PED2-425-12, PED2-425-12,PED2-425-18, PED2-425-20, PED2-425-25, PED2-425-30, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED2-425-35, PED PED2-450-10, PED2-450-12, PED2-450-14, PED2-450-16, PED2-450-18, PED2-450-20, PED2-450-25, PED2-450-30, PED2-450-35, PED2-475-10, PED2-475-12, PED2-475-12, PED2-475-12, PED2-475-12, PED2-475-12, PED2-450-12, PED2-450-12, PED2-450-14, PED2-450-18, PED2-450-12, PED2-450-14, PED2-450-16, PED2-450-18, PED2-450-20, PED2-450-12, PED2-450-12, PED2-450-12, PED2-450-12, PED2-450-12, PED2-450-12, PED2-450-25, PED2-450-30, PED2-450-30, PED PED2-475-14, PED2-475-16, PED2-475-18, PED2-475-20, PED2-475-25, PED2-475-30, PED2-475-35, PED2-500-10, PED2-475-30, PED2-475-30, PED2-475-35, PED2-500-10, PED2-500-10, PED2-475-30, PED2-475-30, PED2-475-30, PED2-475-35, PED2-475-10, PED2-475-10, PED2-475-30, PED2-475-35, PED2-475-10, PED2-475-10, PED2-475-30, PED2-ED2-500-12, PED2-500-14, PED2-500-16, PED2-500-18, PED2-500-20, PED2-500-25, PED2-500-30, PED2-500-35) PED2-500-35, PED2-500-35, PED2-500-35, PED2-500-35, PED2-500-35) PED2-500-35, PED2-500-35, PED2-500-30, PED2-500-30, PED2-500-35, PED2-500-35, PED2-500-30, PED2-500-30, PED2-500-35, PED2-500-35, PED2-500-35,