Medical Device Division · registration 120368Active

Cook Ireland

Name: Cook Ireland — Medical Device Division 120368
Creator: Cook Ireland Limited
Keywords: Cook Ireland, Cook Ireland, 120368, Stents, Vascular, Peripheral, Self-Expanding, Medical Device Division

Hong KongStents, Vascular, Peripheral, Self-ExpandingClass IVCook Ireland Limited

Verified

Official record identity

MDACS listing number: 120368
Model name: Zilver PTX Drug Eluting Peripheral Stent (ZISV6-35-125-5.0-100-PTX, ZISV6-35-125-8.0-100-PTX, ZISV6-35-80-7.0-100-PTX, ZISV6-35-125-5.0-120-PTX, ZISV6-35-125-8.0-120-PTX, ZISV6-35-80-7.0-120-PTX, ZISV6-35-125-5.0-40-PTX, ZISV6-35-125-8.0-40-PTX, ZISV6-35-80-7.0-40-PTX, ZISV6-35-125-5.0-60-PTX, ZISV6-35-125-8.0-60-PTX, ZISV6-35-80-7.0-60-PTX, ZISV6-35-125-5.0-80-PTX, ZISV6-35-125-8.0-80-PTX, ZISV6-35-80-7.0-80-PTX, ZISV6-35-125-6.0-100-PTX, ZISV6-35-80-8.0-100-PTX, ZISV6-35-80-5.0-100-PTX, ZISV6-35-125-6.0-120-PTX, ZISV6-35-80-5.0-120-PTX, ZISV6-35-80-8.0-120-PTX, ZISV6-35-125-6.0-40-PTX, ZISV6-35-80-5.0-40-PTX, ZISV6-35-80-8.0-40-PTX, ZISV6-35-125-6.0-60-PTX, ZISV6-35-80-5.0-60-PTX, ZISV6-35-80-8.0-60-PTX, ZISV6-35-125-6.0-80-PTX, ZISV6-35-80-5.0-80-PTX, ZISV6-35-80-8.0-80-PTX, ZISV6-35-125-7.0-100-PTX, ZISV6-35-80-6.0-100-PTX, ZISV6-35-125-7.0-120-PTX, ZISV6-35-80-6.0-120-PTX, ZISV6-35-125-7.0-40-PTX, ZISV6-35-80-6.0-40-PTX, ZISV6-35-125-7.0-60-PTX, ZISV6-35-80-6.0-60-PTX, ZISV6-35-125-7.0-80-PTX, ZISV6-35-80-6.0-80-PTX, ZISV6-35-125-5.0-140-PTX, ZISV6-35-125-6.0-140-PTX, ZISV6-35-125-7.0-140-PTX, ZISV6-35-80-5.0-140-PTX, ZISV6-35-80-6.0-140-PTX, ZISV6-35-80-7.0-140-PTX)
Registration date: November 14, 2022
Expiry date: November 14, 2027
Source update date: July 15, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Stents, Vascular, Peripheral, Self-Expanding

Published parties

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

Official description

Stents, Vascular, Peripheral, Self-Expanding

Additional source fields

AMD nomenclature code: 20430
Local responsible person phone: 34721688
Published manufacturer address: O'Halloran Road, National Technology Park, Limerick, Ireland
Revision number: e

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.