Medical Device Division · registration 100462Active

Cook Ireland

Name: Cook Ireland — Medical Device Division 100462
Creator: Cook Ireland Limited
Keywords: Cook Ireland, Cook Ireland, 100462, Stents, Biliary, Metallic, Self-Expanding, Medical Device Division

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

Verified

Official record identity

MDACS listing number: 100462
Model name: 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)
Registration date: July 30, 2025
Expiry date: December 30, 2030
Source update date: August 06, 2025
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: 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.