Pure Global
130057
III
current

Stents, Biliary, Metallic, Self-Expandingๆ”ฏๆžถ,่ƒ†้“,้‡‘ๅฑž,่‡ช่†จ่ƒ€

This profile provides complete Hong Kong MDACS registration information for Stents, Biliary, Metallic, Self-Expanding. 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: Stents, Biliary, Metallic, Self-Expanding

็”ขๅ“่ณ‡่จŠ๏ผš ๆ”ฏๆžถ,่ƒ†้“,้‡‘ๅฑž,่‡ช่†จ่ƒ€

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20421
Product Code Detail
20421 Stents, Biliary, Metallic, Self-Expanding
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Cook Ireland Limited
Cook Ireland Limited
Ireland
็ˆฑๅฐ”ๅ…ฐ
O'Halloran Road, National Technology Park, Limerick, Ireland
O'Halloran Road, National Technology Park, Limerick, Ireland
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 16, 2023
Expiry Date
May 16, 2028
Product Models
Evolution Biliary Stent System - Uncovered (EVO-8-9-4-B, EVO-8-9-6-B, EVO-8-9-8-B, EVO-8-9-10-B, EVO-10-11-4-B, EVO-10-11-6-B, EVO-10-11-8-B, EVO-10-11-10-B), Evolution Biliary Stent System - Partially Covered (EVO-PC-8-9-6-B, EVO-PC-8-9-8-B, EVO-PC-10-11-4-B, EVO-PC-10-11-6-B, EVO-PC-10-11-8-B), Evolution Biliary Stent System - Fully Covered (EVO-FC-8-9-6-B, EVO-FC-8-9-8-B, EVO-FC-10-11-4-B, EVO-FC-10-11-6-B, EVO-FC-10-11-8-B)\n
Evolution ่ƒ†้“ๆ”ฏๆžถ็ณป็ปŸ - ๆœช่ฆ†็›–(EVO-8-9-4-Bใ€EVO-8-9-6-Bใ€EVO-8-9-8-Bใ€EVO-8-9-10-Bใ€EVO-10-11-4-Bใ€EVO-10-11-6-Bใ€EVO-10-11-8-Bใ€EVO-10-11-10-B)ใ€Evolution ่ƒ†้“ๆ”ฏๆžถ็ณป็ปŸ - ้ƒจๅˆ†่ฆ†็›–(EVO-PC-8-9-6-Bใ€EVO-PC-) 8-9-8-Bใ€EVO-PC-10-11-4-Bใ€EVO-PC-10-11-6-Bใ€EVO-PC-10-11-8-B)ใ€Evolution ่ƒ†้“ๆ”ฏๆžถ็ณป็ปŸ - ๅ…จ่ฆ†็›–(EVO-FC-8-9-6-Bใ€EVO-FC-8-9-8-Bใ€EVO-FC-10-11-4-Bใ€EVO-FC-10-11-6-Bใ€EVO-FC-10-11-8-B)\n