Pure Global
120331
III
current

Stents, Biliary胆道支架

This profile provides complete Hong Kong MDACS registration information for Stents, Biliary. 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

產品資訊: 胆道支架

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17672
Product Code Detail
17672 Stents, Biliary
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (製造商)
Cook Ireland Limited
Cook Ireland Limited
Ireland
爱尔兰
O'Halloran Road, National Technology Park, Limerick, Ireland
O'Halloran Road, National Technology Park, Limerick, Ireland
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 18, 2022
Expiry Date
September 18, 2027
Product Models
Catton-Huibregtse Biliary Stent Set (CHBS-10-3, CHBS-10-5, CHBS-10-7, CHBS-10-9, CHBS-10-10, CHBS-10-11, CHBS-10-12, CHBS-10-15, CHBS-11.5-5, CHBS-11.5-7, CHBS-11.5-9, CHBS-11.5-10, CHBS-11.5-12, CHBS-11.5-15, CHBS-7-3, CHBS-7-5, CHBS-7-6, CHBS-7-7, CHBS-7-9, CHBS-7-10, CHBS-7-12, CHBS-7-15, CHBS-8.5-5, CHBS-8.5-7, CHBS-8.5-9, CHBS-8.5-12, CHBS-8.5-15), Cotten-Huibregtse Biliary Stent (CHBSO-10-3, CHBSO-10-4, CHBSO-10-5, CHBSO-10-6, CHBSO-10-7, CHBSO-10-8, CHBSO-10-9, CHBSO-10-10, CHBSO-10-11, CHBSO-10-12, CHBSO-10-15, CHBSO-10-18, CHBSO-11.5-5, CHBSO-11.5-7, CHBSO-11.5-8, CHBSO-11.5-9, CHBSO-11.5-10, CHBSO-11.5-12, CHBSO-11.5-15, CHBSO-11.5-18, CHBSO-7-4, CHBSO-7-5, CHBSO-7-7, CHBSO-7-9, CHBSO-7-10, CHBSO-7-12, CHBSO-7-15, CHBSO-7-18, CHBSO-8.5-5, CHBSO-8.5-7, CHBSO-8.5-9, CHBSO-8.5-10, CHBSO-8.5-12, CHBSO-8.5-15, CHBSO-8.5-18), Cotton-Huibregtse Biliary Stent w/ Radiopaque Bands (CHBSO-10-5-RB, CHBSO-10-7-RB, CHBSO-10-9-RB, CHBSO-10-12-RB, CHBSO-10-15-RB, CHBSO-11.5-5-RB, CHBSO-8.5-5-RB, CHBSO-8.5-7-RB, CHBSO-8.5-9-RB, CHBSO-8.5-12-RB), Cotton-Leung (Amsterdam) Biliary Stent Set (CLBS-10-3, CLBS-10-4, CLBS-10-5, CLBS-10-6, CLBS-10-7, CLBS-10-8, CLBS-10-9, CLBS-10-10, CLBS-10-11, CLBS-10-12, CLBS-10-13, CLBS-10-14, CLBS-10-15, CLBS-10-16, CLBS-10-17, CLBS-10-18, CLBS-11.5-3, CLBS-11.5-5, CLBS-11.5-6, CLBS-11.5-7, CLBS-11.5-8, CLBS-11.5-9, CLBS-11.5-10, CLBS-11.5-11, CLBS-11.5-12, CLBS-11.5-13, CLBS-11.5-14, CLBS-11.5-15, CLBS-11.5-16, CLBS-11.5-17, CLBS-11.5-18, CLBS-5-5, CLBS-5-7, CLBS-5-9, CLBS-5-12, CLBS-7-3, CLBS-7-4, CLBS-7-5, CLBS-7-6, CLBS-7-7, CLBS-7-8, CLBS-7-9, CLBS-7-10, CLBS-7-11, CLBS-7-12, CLBS-7-13, CLBS-7-14, CLBS-7-15, CLBS-7-16, CLBS-7-17, CLBS-7-18, CLBS-8-5, CLBS-8.5-3, CLBS-8.5-5, CLBS-8.5-6, CLBS-8.5-7, CLBS-8.5-8, CLBS-8.5-9, CLBS-8.5-10, CLBS-8.5-11, CLBS-8.5-12, CLBS-8.5-13, CLBS-8.5-14, CLBS-8.5-15, CLBS-8.5-16, CLBS-8.5-17, CLBS-8.5-18), Cotton-Leung Biliary Stent (CLSO-5-3, CLSO-5-5, CLSO-5-7, CLSO-5-9, CLSO-5-12, CLSO-5-15, CLSO-7-2, CLSO-7-3, CLSO-7-4, CLSO-7-5, CLSO-7-6, CLSO-7-7, CLSO-7-8, CLSO-7-9, CLSO-7-10, CLSO-7-11, CLSO-7-12, CLSO-7-13, CLSO-7-14, CLSO-7-15, CLSO-7-16, CLSO-7-17, CLSO-7-18, CLSO-7-19, CLSO-7-20, CLSO-7-21, CLSO-8.5-3, CLSO-8.5-5, CLSO-8.5-6 , CLSO-8.5-7, CLSO-8.5-8, CLSO-8.5-9, CLSO-8.5-10, CLSO-8.5-11, CLSO-8.5-12, CLSO-8.5-13, CLSO-8.5-14, CLSO-8.5-15, CLSO-8.5-16, CLSO-8.5-17, CLSO-8.5-18, CLSO-8.5-20, CLSO-10-2, CLSO-10-3, CLSO-10-4, CLSO-10-5, CLSO-10-6, CLSO-10-7, CLSO-10-8, CLSO-10-9, CLSO-10-10, CLSO-10-11, CLSO-10-12, CLSO-10-13, CLSO-10-14, CLSO-10-15, CLSO-10-16, CLSO-10-17, CLSO-10-18, CLSO-10-19, CLSO-10-20, CLSO-10-21, CLSO-11.5-3, CLSO-11.5-5, CLSO-11.5-6 , CLSO-11.5-7, CLSO-11.5-8, CLSO-11.5-9, CLSO-11.5-10, CLSO-11.5-11, CLSO-11.5-12, CLSO-11.5-13, CLSO-11.5-14, CLSO-11.5-15, CLSO-11.5-16, CLSO-11.5-17, CLSO-11.5-18, CLSO-11.5-20), Plastic Biliary Stent (PBS-7-5, PBS-7-7, PBS-7-9, PBS-7-12, PBS-7-15, PBS-8.5-5, PBS-8.5-7, PBS-8.5-9, PBS-8.5-12, PBS-8.5-15, PBS-10-5, PBS-10-7, PBS-10-9, PBS-10-12, PBS-10-15, PBS-11.5-5, PBS-11.5-7, PBS-11.5-9, PBS-11.5-12, PBS-11.5-15), ST-2 Soehendra Tannenbaum Biliary Stent (TTSO-10-5, TTSO-10-6, TTSO-10-7, TTSO-10-8, TTSO-10-9, TTSO-10-10, TTSO-10-11, TTSO-10-12, TTSO-10-13, TTSO-10-14, TTSO-10-15, TTSO-11.5-5, TTSO-11.5-6, TTSO-11.5-7, TTSO-11.5-8, TTSO-11.5-9, TTSO-11.5-10, TTSO-11.5-11, TTSO-11.5-12, TTSO-11.5-13, TTSO-11.5-14, TTSO-11.5-15, TTSO-8.5-5, TTSO-8.5-6, TTSO-8.5-7, TTSO-8.5-8, TTSO-8.5-9, TTSO-8.5-10, TTSO-8.5-11, TTSO-8.5-12, TTSO-8.5-13, TTSO-8.5-14, TTSO-8.5-15), Zimmon Biliary Stent Set (ZEBD-10-2, ZEBD-10-3, ZEBD-10-4, ZEBD-10-5, ZEBD-10-6, ZEBD-10-7, ZEBD-10-8, ZEBD-10-9, ZEBD-10-10, ZEBD-10-12, ZEBD-10-15, ZEBD-5-3, ZEBD-5-4, ZEBD-5-5, ZEBD-5-7, ZEBD-5-9, ZEBD-5-10, ZEBD-5-12, ZEBD-5-15, ZEBD-6-4, ZEBD-6-7, ZEBD-6-10, ZEBD-6-12, ZEBD-7-2, ZEBD-7-3, ZEBD-7-4, ZEBD-7-5, ZEBD-7-7, ZEBD-7-6, ZEBD-7-8, ZEBD-7-9, ZEBD-7-10, ZEBD-7-12, ZEBD-7-15, ZEBD-7-18, ZEBD-8-5, ZEBD-8-7, ZEBD-8-9, ZEBD-8-12, ZEBD-8-15, ZEBD-11.5-5, ZEBD-11.5-7, ZEBD-11.5-9, ZEBD-11.5-12, ZEBD-11.5-15), Zimmon Biliary stent (ZSO-10-2, ZSO-10-3, ZSO-10-4, ZSO-10-5, ZSO-10-6, ZSO-10-7, ZSO-10-8, ZSO-10-9, ZSO-10-10, ZSO-10-12, ZSO-10-15, ZSO-5-3, ZSO-5-4, ZSO-5-5, ZSO-5-7, ZSO-5-9, ZSO-5-10, ZSO-5-12, ZSO-5-15, ZSO-6-4, ZSO-6-7, ZSO-6-9, ZSO-6-10, ZSO-7-3, ZSO-7-4, ZSO-7-5, ZSO-7-6, ZSO-7-7, ZSO-7-9, ZSO-7-10, ZSO-7-12, ZSO-7-15, ZSO-7-16, ZSO-7-18, ZSO-8-4, ZSO-8-5, ZSO-8-7, ZSO-8-9, ZSO-8-10, ZSO-8-12, ZSO-8-15), Solus Double Pigtail Stent with Introducer (ZSS-10-1-RB, ZSS-10-3-RB, ZSS-10-4-RB, ZSS-10-5-RB, ZSS-10-7-RB, ZSS-10-9-RB, ZSS-10-10-RB, ZSS-10-12-RB, ZSS-10-15-RB)
卡顿-惠布雷特双胆支架套件(CHBS-10-3、CHBS-10-5、CHBS-10-7、CHBS-10-9、CHBS-10-10、CHBS-10-11、CHBS-10-12、CHBS-10-15、CHBS-11.5-5、CHBS-11.5-7、CHBS-11.11. 5-9, CHBS-11.5-10, CHBS-11.5-12, CHBS-11.5-15, CHBS-7-3, CHBS-7-5, CHBS-7-6, CHBS-7-7, CHBS-7-9, CHBS-7-10, CHBS-7-12, CHBS-7-15, CHBS-8.5-5, CHBS-8.5-7, CHBS-8.5-9, CHBS-8.5-12, CHBS-8.5-15), Cotten-Huibregtse 胆道支架 (CHBSO-10-3, CHBSO-10-4, CHBSO-10-5, CHBSO-10-6, CHBSO-10-7, CHBSO-10-8, CHBSO-10-9, CHBSO-10-10,CHBSO-10-11, CHBSO-10-12, CHBSO-10-15, CHBSO-10-18, CHBSO-11.5-5, CHBSO-11.5-7, CHBSO-11.5-8, CHBSO-11.5-9, CHBSO-11.5-10, CHBSO-11.11.11.5-12, CHBSO-11.5-15, CHBSO-11.5-18, CHBSO-7-4, CHBSO-7-5, CHBSO-7-7-7, CHBSO-7-9, CHBSO-7-10, CHBSO-7-12, CHBSO-7-15, CHBSO-7-18, CHBSO-8.5-5, CHBSO-8.5-7, CHBSO-8.5-9, CHBSO-8.5-10, CHBSO-8.5-12, CHBSO-8.5-15, CHBSO-8.5-18), 棉-惠布雷特双胆支架,带不透射线的带(CHBSO-10-5-RB, CHBSO-10-7-RB, CHBSO-10-9-RB, CHBSO-10-12-RB, CHBSO-10-15-RB,CHBSO-11.5-5-RB, CHBSO-8.5-5-RB, CHBSO-8.5-7-RB, CHBSO-8.5-9-RB, CHBSO-8.5-12-RB), Cotton-Leung (阿姆斯特丹) 胆道支架套件 (CLBS-10-3, CLBS-10-4, CLBS-10-5, CLBS-10-6, CLBS-10-7, CLBS-10-8, CLBS-10-9, CLBS-10-10, CLBS-10-11, CLBS-10-12, CLBS-10-13, CLBS-10-14, CLBS-10-15, CLBS-10-16, CLBS-10-17, CLBS-10-18, CLBS-11.11.11.5-3, CLBS-11.5-5, CLBS-11.5-6, CLBS-11.5-7, CLBS-11.5-8, CLBS-11.5-9, CLBS-11.5-10, CLBS-11.5-11, CLBS-11.5-12, CLBS-11.5-13, CLBS-11.5-14, CLBS-11.5-15, CLBS-11.5-16,CLBS-11.5-17, CLBS-11.5-18, CLBS-5-5, CLBS-5-7, CLBS-5-9, CLBS-5-12, CLBS-7-3, CLBS-7-4, CLBS-7-5, CLBS-7-6, CLBS-7-7-7, CLBS-7-8, CLBS-7-9, CLBS-7-10, CLBS-7-11, CLBS-7-12, CLBS-7-13, CLBS-7-14, CLBS-7-15, CLBS-7-16, CLBS-7-17, CLBS-7-18, CLBS-8-5, CLBS-8.8.5-3, CLBS-8.5-5, CLBS-8.5-6, CLBS-8.5-7, CLBS-8.5-8, CLBS-8.5-9, CLBS-8.5-10, CLBS-8.5-11, CLBS-8.5-12, CLBS-8.5-13, CLBS-8.5-14, CLBS-8.5-15, CLBS-8.5-16, CLBS-8.5-17, CLBS-8.5-18), 棉-梁胆架 (CLSO-5-3, CLSO-5-5,CLSO-5-7, CLSO-5-9, CLSO-5-12, CLSO-5-15, CLSO-7-2, CLSO-7-3, CLSO-7-4, CLSO-7-5, CLSO-7-6, CLSO-7-7, CLSO-7-8, CLSO-7-9, CLSO-7-10, CLSO-7-11, CLSO-7-12, CLSO-7-13, CLSO-7-14, CLSO-7-15, CLSO-7-16, CLSO-7-17, CLSO-7-18, CLSO-7-19, CLSO-7-20, CLSO-7-21, CLSO-8.5-3, CLSO-8.5-5, CLSO-8.5-6 , CLSO-8.5-7, CLSO-8.5-8, CLSO-8.5-9, CLSO-8.5-10, CLSO-8.5-11, CLSO-8.5-12, CLSO-8.5-13, CLSO-8.5-14, CLSO-8.5-15, CLSO-8.5-16, CLSO-8.5-17, CLSO-8.5-18, CLSO-8.5-20, CLSO-10-2, CLSO-10-3, CLSO-10-4,CLSO-10-5, CLSO-10-6, CLSO-10-7, CLSO-10-8, CLSO-10-9, CLSO-10-10, CLSO-10-11, CLSO-10-12, CLSO-10-13, CLSO-10-14, CLSO-10-15, CLSO-10-16, CLSO-10-17, CLSO-10-18, CLSO-10-19, CLSO-10-20, CLSO-10-21, CLSO-11.5-3, 氯-11.5-5, 氯-11.5-6 , 氯-11.5-7, 氯-11.5-8, 氯-11.5-9, 氯-11.5-10, 氯-11.5-11, 氯-11.5-12, 氯-11.5-13, 氯-11.5-14, 氯-11.5-15, 氯-11.5-16, 氯-11.5-17, 氯-11.5-18, 氯-11.5-20), 塑料胆架 (PBS-7-5, PBS-7-7, PBS-7-9, PBS-7-12, PBS-7-15,PBS-8.5-5, PBS-8.5-7, PBS-8.5-9, PBS-8.5-12, PBS-8.5-15, PBS-10-5, PBS-10-7, PBS-10-9, PBS-10-12, PBS-10-15, PBS-11.5-5, PBS-11.5-7, PBS-11.5-9, PBS-11.11.1.5.9. 1.5-12, PBS-11.5-15), ST-2 索亨德拉坦南鲍姆胆汁支架 (TTSO-10-5, TTSO-10-6, TTSO-10-7, TTSO-10-8, TTSO-10-9, TTSO-10-10, TTSO-10-11, TTSO-10-12, TTSO-10-13, TTSO-10-14, TTSO-10-15, TTSO-11.5-5, TTSO-11.5-6, TTSO-11.5-7, TTSO-11.5-8, TTSO-11.5-9, TTSO-11.5-10, TTSO-11.5-11, TTSO-11.5-12, TTSO-11.5-13, TTSO-11.5-14, TTSO-11.5-15,TTSO-8.5-5, TTSO-8.5-6, TTSO-8.5-7, TTSO-8.5-8, TTSO-8.5-9, TTSO-8.8.8.5-10, TTSO-8.5-11, TTSO-8.5-12, TTSO-8.5-13, TTSO-8.5-14, TTSO-8.5-15), Zimmon 胆道支架套件 (ZEBD-10-2, ZEBD-100-10 -3, ZEBD d-10-4, ZEBD-10-5, ZEBD-10-6, ZEBD-10-7, ZEBD-10-8, ZEBD-10-9, ZEBD-10-10, ZEBD-10-12, ZEBD-10-15, ZEBD-5-3, ZEBD-5-4, ZEBD-5-5, ZEBD-5-7, ZEBD-5-9, ZEBD-5-10, ZEBD-5-12, ZEBD-5-15, ZEBD-6-4, ZEBD-6-7, ZEBD-6-10, ZEBD-6-12, ZEBD-7-2, ZEBD-7-3, ZEBD-7-4, ZEBD-7-5, ZEBD-7-7-7, ZEBD-7-6, ZEBD-7-8, ZEBD-7-9, ZEBD-7-10, ZEBD-7-12, ZEBD-7-15, ZEBD-7-18, ZEBD-8-5, ZEBD-8-7, ZEBD-8-9, ZEBD-8-12, ZEBD-8-15, ZEBD-11.5-5, ZEBD-11.5-7, ZEBD-11.11.11.5-9, ZEBD-11.5-12, ZEBD-11.5-15), Zimmon 胆道支架 (ZSO-10-2, ZSO-10-3, ZSO-10-4, ZSO-10-5, ZSO-10-6, ZSO-10-7, ZSO-10-8, ZSO-10-9, ZSO-10-10, ZSO-10-12 , ZSO-10-15, ZSO-5-3, ZSO-5-4, ZSO-5-5, ZSO-5-7, ZSO-5-9, ZSO-5-10, ZSO-5-12, ZSO-5-15, ZSO-6-4, ZSO-6-7, ZSO-6-9, ZSO-6-10, ZSO-7-3, ZSO-7-4, ZSO-7-5, ZSO-7-6, ZSO-7-7, ZSO-7-9, ZSO-7-10, ZSO-7-12, ZSO-7-15, ZSO-7-16, ZSO-7-18, ZSO-8-4, ZSO-8-5, ZSO-8-7, ZSO-8-9, ZSO-8-10, ZSO-8-12, ZSO-8-15), 带介绍人的Solus双尾纤支架(ZSS-10-1-RB, ZSS-10-3-RB, ZSS-10-4-RB, ZSS-10-5-RB, ZSS-10-7-RB, ZSS-10-9-RB, ZSS-10-10-RB, ZSS-10-12-RB, ZSS-10-15-RB)