240213
IV
current
Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversionๆฏๆถใ่ก็ฎกใ้ข ๅ ๅจ่ใๅจ่็ค่กๆตๅๆต
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
็ขๅ่ณ่จ๏ผ ๆฏๆถใ่ก็ฎกใ้ข ๅ ๅจ่ใๅจ่็ค่กๆตๅๆต
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
Manufacturer (่ฃฝ้ ๅ)
Acandis GmbH
Acandis Gmbh
Germany
ๅพทๅฝ
Theodor-Fahrner-Strasse 6, 75177 Pforzheim, Germany
Theodor-Fahrner-Strasse 6, 75177 ๆฎ็ฆๅฐ่จๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็พ่ฐทๅป็็งๆๆ้ๅ
ฌๅธ
31881638
Regulatory Timeline
Registration Date
June 06, 2024
Expiry Date
June 05, 2029
Product Models
Derivo Embolisation Device (01-000330, 01-000331, 01-000332, 01-000333, 01-000334, 01-000335, 01-000336, 01-000337, 01-000338, 01-000339, 01-000340, 01-000341, 01-000342, 01-000343, 01-000344, 01-000345, 01-000346, 01-000347, 01-000348, 01-000349, 01-000350, 01-000351, 01-000353, 01-000354, 01-000355, 01-000356, 01-000357, 01-000358, 01-000359, 01-000352, 01-000360, 01-000361, 01-000362, 01-000363, 01-000364, 01-000365, 01-000366, 01-000367, 01-000381, 01-000382, 01-000383, 01-000384, 01-000385, 01-000408, 01-000409, 01-000410, 01-000411, 01-000412, 01-000413, 01-000414, 01-000415)
่ก็ๆ ๅก่ฃ
็ฝฎ (01-000330, 01-000331, 01-000332, 01-000333, 01-000334, 01-000335, 01-000336, 01-000337, 01-000338, 01-000339, 01-000340, 01-000341, 01-000342, 01-000343, 01-000344, 01-000345, 01-000346, 01-000347, 01-000348, 01-000349, 01-000349, 01-000 ็ฅจไปท:350ใ01-000351ใ01-000353ใ01-000354ใ01-000355ใ01-000356ใ01-000357ใ01-000358ใ01-000359ใ01-000352ใ01-000360ใ01-000361ใ01-000362ใ01-000363ใ01-000364ใ01-000365ใ01-000366ใ01-000367ใ01-000381ใ01-000382ใ01-000383ใ01-000384ใ01-000385, 01-000408, 01-000409, 01-000410, 01-000411, 01-000412, 01-000413, 01-000414, 01-000415)