Pure Global
230148
IV
current

Stents, Vascular, Intracranial Artery, Drug-Elutingๆ”ฏๆžถใ€่ก€็ฎกใ€้ข…ๅ†…ๅŠจ่„‰ใ€่ฏ็‰ฉๆด—่„ฑ

This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Intracranial Artery, Drug-Eluting. 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

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
28243
Product Code Detail
28243 Stents, Vascular, Intracranial Artery
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Acandis GmbH
Acandis Gmbh
Germany
ๅพทๅ›ฝ
Theodor-Fahrner-Strasse 6, 75177 Pforzheim, Germany
Theodor-Fahrner-Strasse 6, 75177 ๆ™ฎ็ฆๅฐ”่Œจๆตทๅง†, ๅพทๅ›ฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็™พ่ฐทๅŒป็–—็ง‘ๆŠ€ๆœ‰้™ๅ…ฌๅธ
31881638
Regulatory Timeline
Registration Date
September 02, 2024
Expiry Date
April 27, 2028
Product Models
DERIVO 2 heal Embolisation Device (01-104001, 01-104002, 01-104003, 01-104004, 01-104005, 01-104006, 01-104007, 01-104008, 01-104009, 01-104010, 01-104011, 01-104012, 01-104013 , 01-104014 , 01-104015 , 01-104016 , 01-104017 , 01-104018 , 01-104019 , 01-104020 , 01-104021 , 01-104022 , 01-104023 , 01-104024 , 01-104025 , 01-104026 , 01-104027 , 01-104028 , 01-104029 , 01-104030 , 01-104031 , 01-104032 , 01-104033 , 01-104034, 01-104035, 01-104036, 01-104037, 01-104038, 01-104039, 01-104040, 01-104041, 01-104042, 01-104043, 01-104044, 01-104045, 01-104046, 01-104047, 01-104048, 01-104049, 01-104050, 01-104051, 01-104052, 01-104053, 01-104054, 01-104055, 01-104056, 01-104057, 01-104058, 01-104059 , 01-104060 , 01-104061 , 01-104062 , 01-104063 , 01-104064 , 01-104065, 01-104066, 01-104067, 01-104068, 01-104069, 01-104070, 01-104071, 01-104072, 01-104073, 01-104074)
DERIVO 2 ๆ„ˆๅˆๆ “ๅกž่ฃ…็ฝฎ (01-104001, 01-104002, 01-104003, 01-104004, 01-104005, 01-104006, 01-104007, 01-104008, 01-104009, 01-104010, 01-104011, 01-104012, 01-104013 , 01-104014 , 01-104015 , 01-104016 , 01-104017 , 01-104018 , 01-104019 , 01-10402 0 , 01-104021 , 01-104022 , 01-104023 , 01-104024 , 01-104025 , 01-104026 , 01-104027 , 01-104028 , 01-104029 , 01-104030 , 01-104031 , 01-104032 , 01-104033 , 01-104034, 01-104035, 01-104036, 01-104037, 01-104038, 01-104039, 01-104040, 01-104041, 01-104042, 01-104043, 01-104044, 01-104045, 01-104046, 01-104047, 01-104048, 01-104049, 01-104050, 01-104051, 01-104052, 01-104053, 01-104054, 01-104055, 01-104056, 01-104057, 01-104058, 01-104059 , 01-104060 , 01-104061 , 01-104062 , 01-104063 , 01-104064 , 01-104065, 01-104066, 01-104067, 01-104068, 01-104069, 01-104070, 01-104071, 01-104072, 01-104073, 01-104074)