240256
IV
current
Catheters, Vascular, Angioplasty, Balloon, Intracranial Arteryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใ้ข ๅ ๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery. 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: Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใ้ข ๅ ๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
32030
Product Code Detail
32030 Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery
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
July 11, 2024
Expiry Date
July 10, 2029
Product Models
NeuroSpeed PTA Balloon Catheter (01-000600, 01-000601, 01-000602, 01-000603, 01-000604, 01-000605, 01-000610, 01-000611, 01-000612, 01-000613, 01-000614, 01-000615)
NeuroSpeed PTA ็ๅๅฏผ็ฎก(01-000600ใ01-000601ใ01-000602ใ01-000603ใ01-000604ใ01-000605ใ01-000610ใ01-000611ใ01-000612ใ01-000613ใ01-000614ใ01-000615)