Pure Global
180302
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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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
August 10, 2023
Expiry Date
August 22, 2028
Product Models
Acclino flex plus Stent (01-001122, 01-001123, 01-001124, 01-001125, 01-001126, 01-001132, 01-001133, 01-001134, 01-001135, 01-001136, 01-001142, 01-001143, 01-001144, 01-001145, 01-001146, 01-001152, 01-001153, 01-001154, 01-001155, 01-001156, 01-001162, 01-001163, 01-001164, 01-001165, 01-001166, 01-001173, 01-001174, 01-001175, 01-001176, 01-001193, 01-001194, 01-001195, 01-001196, 00-001213, 00-001215, 00-001217, 00-001221)
Acclino flex plus ๆ”ฏๆžถ (01-001122, 01-001123, 01-001124, 01-001125, 01-001126, 01-001132, 01-001133, 01-001134, 01-001135, 01-001136, 01-001142, 01-001143, 01-001144, 01-001145, 01-001146, 01-001152, 01-001153, 01-001154, 01-001154, 01-001145, 01-001145, 01-001146, 01-001152, 01-001153, 01-001154, 01-001154, 01-001145, 01-001146, 01-001152, 01-001153, 01-001154, 01-001154, 01-001144, 01-001146, 01-001152, 01-001153, 01-001153, 01-001154, 01-001154, 01-001154, 01-001154, 01-001145, 01-001145, 01-001145, 01-001145, 01-001153, 01-001153, 01-001153, 01-001153, 01-001154, 01-001154, 01-001154, 01-001154, 01-001154, 01-001154, 01-001153, 01-001153, 01-01-00 01-001155, 01-001156, 01-001162, 01-001163, 01-001164, 01-001165, 01-001166, 01-001173, 01-001174, 01-001175, 01-001176, 01-001193, 01-001194, 01-001195, 01-001196, 00-001213, 00-001215, 00-001217, 00-001221)