Pure Global
240277
IV
current

Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversionๆ”ฏๆžถใ€่ก€็ฎกใ€้ข…ๅ†…ๅŠจ่„‰ใ€ๅŠจ่„‰็˜ค่ก€ๆตๅˆ†ๆต

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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
35297
Product Code Detail
35297 Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversion
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
47900 Bayside Parkway, Fremont, California, 94538, USA
47900 Bayside Parkway, Fremont, California, 94538, ็พŽๅ›ฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็™พ่ฐทๅŒป็–—็ง‘ๆŠ€ๆœ‰้™ๅ…ฌๅธ
31881638
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
Surpass Evolve Flow Diverter System (FD25012, FD25013, FD25014, FD25015, FD25016, FD25017, FD25018, FD25019, FD25020, FD32512, FD32513, FD32514, FD32515, FD32516, FD32517, FD32518, FD32519, FD32520, FD32521, FD32522, FD32525, FD32530, FD40012, FD40013, FD40014, FD40015, FD40016, FD40017, FD40018, FD40019, FD40020, FD40021, FD40022, FD40025, FD40030, FD40040, FD45012, FD45013, FD45014, FD45015, FD45016, FD45017, FD45018, FD45019, FD45020, FD45021, FD45022, FD45025, FD45030, FD45040, FD50012, FD50013, FD50014, FD50015, FD50016, FD50017, FD50018, FD50019, FD50020, FD50021, FD50022, FD50025, FD50030, FD50040)
่ถ…่ถŠ Evolve ๅˆ†ๆตๅ™จ็ณป็ปŸ(FD25012ใ€FD25013ใ€FD25014ใ€FD25015ใ€FD25016ใ€FD25017ใ€FD25018ใ€FD25019ใ€FD25020ใ€FD32512ใ€FD32513ใ€FD32514ใ€FD32515ใ€FD32516ใ€FD32517ใ€FD32518ใ€FD32519ใ€FD32520ใ€FD32521ใ€FD32522ใ€FD32525ใ€FD32530ใ€FD40012ใ€FD40013ใ€FD40014 FD40015ใ€FD40016ใ€FD40017ใ€FD40018ใ€FD40019ใ€FD40020ใ€FD40021ใ€FD40022ใ€FD40025ใ€FD40030ใ€FD40040ใ€FD45012ใ€FD45013ใ€FD45014ใ€FD45015ใ€FD45016ใ€FD45017ใ€FD45018ใ€FD45019ใ€FD45020ใ€FD45021ใ€FD45022ใ€FD45025ใ€FD45030ใ€FD45040ใ€FD50012ใ€ FD50013ใ€FD50014ใ€FD50015ใ€FD50016ใ€FD50017ใ€FD50018ใ€FD50019ใ€FD50020ใ€FD50021ใ€FD50022ใ€FD50025ใ€FD50030ใ€FD50040)