Medical Device Division · registration 120331Active

Cook Ireland

Name: Cook Ireland — Medical Device Division 120331
Creator: Cook Ireland Limited
Keywords: Cook Ireland, Cook Ireland, 120331, Stents, Biliary, Medical Device Division

Hong KongStents, BiliaryClass IIICook Ireland Limited

Verified

Official record identity

MDACS listing number: 120331
Model name: Cotton-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), Cotton-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-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-8.5-3, 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-7-6, ZEBD-7-7, 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), 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)
Registration date: July 10, 2025
Expiry date: September 18, 2027
Source update date: June 29, 2026
Status: Active

Classification

Risk class: Class III
Published category: Stents, Biliary

Published parties

Registrant / registration holder: Cook Asia Ltd
Manufacturer: Cook Ireland Limited

Official description

Stents, Biliary

Additional source fields

AMD nomenclature code: 17672
Local responsible person phone: 34721688
Published manufacturer address: O'Halloran Road, National Technology Park, Limerick, Ireland
Revision number: d

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.