Pure Global
240016
IV
current

Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusionๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰ใ€็Œๆณจ

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

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰ใ€็Œๆณจ

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
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
9965 Federal Drive, Colorado Springs, Colorado, 80921, USA
9965่”้‚ฆๅคง้“, ็ง‘็ฝ—ๆ‹‰ๅคšๆ–ฏๆ™ฎๆž—ๆ–ฏ, ็ง‘็ฝ—ๆ‹‰ๅคšๅทž, 80921, ็พŽๅ›ฝ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅˆ›ๅŠ›้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
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 ๅˆ’็—•็ƒๅ›Šๅฏผ็ฎก(2200-2006-Bใ€2200-2010-Bใ€2200-2015-Bใ€2200-2020-Bใ€2200-2506-Bใ€2200-2510-Bใ€2200-2515-Bใ€2200-2520-Bใ€2200-3006-Bใ€2200-3010-Bใ€2200-3015-Bใ€2200-3020-Bใ€2200-3506-Bใ€2200-3510-Bใ€2200-3515-Bใ€2200-3520-B)