240016
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusionๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ็ๆณจ
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion. 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, Coronary, Perfusion
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ็ๆณจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17521
Product Code Detail
17521 Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Philips Image Guided Therapy Corporation
Royal Philips
United States
็พๅฝ
9965 Federal Drive, Colorado Springs, Colorado, 80921, USA
9965่้ฆๅคง้, ็ง็ฝๆๅคๆฏๆฎๆๆฏ, ็ง็ฝๆๅคๅท, 80921, ็พๅฝ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅๅ้ฆๆธฏๆ้ๅ
ฌๅธ
28776787
Regulatory Timeline
Registration Date
January 31, 2024
Expiry Date
January 31, 2029
Product Models
AngioSculpt Evo Scoring Balloon Catheter (2200-2006-B, 2200-2010-B, 2200-2015-B, 2200-2020-B, 2200-2506-B, 2200-2510-B, 2200-2515-B, 2200-2520-B, 2200-3006-B, 2200-3010-B, 2200-3015-B, 2200-3020-B, 2200-3506-B, 2200-3510-B, 2200-3515-B, 2200-3520-B)
AngioSculpt Evo ๅ็็ๅๅฏผ็ฎก(2200-2006-Bใ2200-2010-Bใ2200-2015-Bใ2200-2020-Bใ2200-2506-Bใ2200-2510-Bใ2200-2515-Bใ2200-2520-Bใ2200-3006-Bใ2200-3010-Bใ2200-3015-Bใ2200-3020-Bใ2200-3506-Bใ2200-3510-Bใ2200-3515-Bใ2200-3520-B)

