Pure Global
241065
IV
current

Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Š

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon. 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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Blue Medical Devices B.V
Blue Medical Devices B.V
Netherlands
่ทๅ…ฐ
Panovenweg 7, 5708 HR Helmond, The Netherlands
Panovenweg 7, 5708 HR ่ตซๅฐ”่’™ๅพท, ่ทๅ…ฐ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅˆ›ๅŠ›้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
28776787
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
SUMMIT CTO Catheter (SUM1110, SUM1115, SUM1120, SUM1210, SUM1215, SUM1220, SUM1510, SUM1515, SUM1520)
SUMMIT CTO ๅฏผ็ฎก(SUM1110ใ€SUM1115ใ€SUM1120ใ€SUM1210ใ€SUM1215ใ€SUM1220ใ€SUM1510ใ€SUM1515ใ€SUM1520)