Pure Global
100462
III
current

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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

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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
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DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
Cook Ireland Limited
Cook Ireland Limited
O'Halloran Road, National Technology Park, Limerick, IRELAND
O'Halloran Road, National Technology Park, Limerick, IRELAND
Authorised Representative (AR)
34721688
Regulatory Timeline
Registration Date
January 19, 2023
Expiry Date
December 31, 2025
Product Models
Zilver 635 Biliary Stent (ZILBS-635-6-4, ZILBS-635-8-4, ZILBS-635-10-4, ZILBS-635-6-6, ZILBS-635-8-6, ZILBS-635-10-6, ZILBS-635-6-8, ZILBS-635-8-8, ZILBS-635-10-8, ZILBS-635-10-10, ZILBS-635-10-12, ZILBS-635-8-10, ZILBS-635-8-12, ZILBS-635-6-10, ZILBS-635-6-12)
Zilver 635 ่ƒ†ๆฑๆ”ฏๆžถ (ZILBS-635-6-4, ZILBS-635-8-4, ZILBS-635-10-4, ZILBS-635-6-6, ZILBS-635-8-6, ZILBS-635-10-6, ZILBS-635-6-8, ZILBS-635-8-8, ZILBS-635-10-8, ZILBS-635-10-10, ZILBS-635-10-12, ZILBS-635-8-10, ZILBS-635-8-12, ZILBS-635-6-10, ZILBS-635-6-12)