Medical Device Division · registration 130057Active

Cook Ireland

Name: Cook Ireland — Medical Device Division 130057
Creator: Cook Ireland Limited
Keywords: Cook Ireland, Cook Ireland, 130057, Stents, Biliary, Metallic, Self-Expanding, Medical Device Division

Hong KongStents, Biliary, Metallic, Self-ExpandingClass IIICook Ireland Limited

Verified

Official record identity

MDACS listing number: 130057
Model name: 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)
Registration date: May 16, 2023
Expiry date: May 16, 2028
Source update date: June 30, 2026
Status: Active

Classification

Risk class: Class III
Published category: Stents, Biliary, Metallic, Self-Expanding

Published parties

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

Official description

Stents, Biliary, Metallic, Self-Expanding

Additional source fields

AMD nomenclature code: 20421
Local responsible person phone: 34721688
Published manufacturer address: O'Halloran Road, National Technology Park, Limerick, Ireland
Revision number: b

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.