Pure Global
180064
IV
current

Stent/Grafts, Vascularๆ”ฏๆžถ/็งปๆค็‰ฉ,่ก€็ฎก

This profile provides complete Hong Kong MDACS registration information for Stent/Grafts, Vascular. 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: Stent/Grafts, Vascular

็”ขๅ“่ณ‡่จŠ๏ผš ๆ”ฏๆžถ/็งปๆค็‰ฉ,่ก€็ฎก

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18585
Product Code Detail
18585 Stent/Grafts, Vascular
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
ev3, Inc.
Ev3, Inc.
United States
็พŽๅ›ฝ
4600 Nathan Lane North, Plymouth, Minnesota 55442, USA
4600 Nathan Lane North, ๆ™ฎๅˆฉ่Œ…ๆ–ฏ, ๆ˜Žๅฐผ่‹่พพๅทž 55442, USA
Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 04, 2023
Expiry Date
April 16, 2028
Product Models
Protege RX Self-Expanding Peripheral Stent System (SEPX-8-6-30-135, SEPX-8-6-40-135, SEPX-10-7-30-135, SEPX-10-7-40-135, SEPX-6-20-135, SEPX-6-30-135, SEPX-6-40-135, SEPX-6-60-135, SEPX-7-20-135, SEPX-7-30-135, SEPX-7-40-135, SEPX-7-60-135, SEPX-8-20-135, SEPX-8-30-135, SEPX-8-40-135, SEPX-8-60-135, SEPX-9-20-135, SEPX-9-30-135, SEPX-9-40-135, SEPX-9-60-135, SEPX-10-20-135, SEPX-10-30-135, SEPX-10-40-135, SEPX-10-60-135)
Protege RX ่‡ช่†จ่ƒ€ๅค–ๅ‘จๆ”ฏๆžถ็ณป็ปŸ (SEPX-8-6-30-135, SEPX-8-6-40-135, SEPX-10-7-30-135, SEPX-10-7-40-135, SEPX-6-20-135, SEPX-6-30-135, SEPX-6-40-135, SEPX-6-60-135, SEPX-7-20-135, SEPX-7-30-135, SEPX-7-40-135, SEPX -7-60-135, SEPX-8-20-135, SEPX-8-30-135, SEPX-8-40-135, SEPX-8-60-135, SEPX-9-20-135, SEPX-9-30-135, SEPX-9-40-135, SEPX-9-60-135, SEPX-10-20-135, SEPX-10-30-135, SEPX-10-40-135, SEPX-10-60-135)