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Medical Device Division · registration 130186Active

William Cook Europe

Hong KongStent/Grafts, Vascular, AorticClass IVWilliam Cook Europe ApS
Official record identity
MDACS listing number
130186
Model name
Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction System (ZDEG-P-22-79-PF, ZDEG-P-22-117-PF, ZDEG-P-24-79-PF, ZDEG-P-24-117-PF, ZDEG-P-26-79-PF, ZDEG-P-26-136-PF, ZDEG-P-28-82-PF, ZDEG-P-28-142-PF, ZDEG-P-28-202-PF, ZDEG-P-30-82-PF, ZDEG-P-30-142-PF, ZDEG-P-30-202-PF, ZDEG-P-32-82-PF, ZDEG-P-32-142-PF, ZDEG-P-32-202-PF, ZDEG-P-34-79-PF, ZDEG-P-34-154-PF, ZDEG-P-34-204-PF, ZDEG-P-36-79-PF, ZDEG-P-36-154-PF, ZDEG-P-36-204-PF, ZDEG-P-38-79-PF, ZDEG-P-38-154-PF, ZDEG-P-38-204-PF, ZDEG-P-40-83-PF, ZDEG-P-40-164-PF, ZDEG-P-40-218-PF, ZDEG-P-42-83-PF, ZDEG-P-42-164-PF, ZDEG-P-42-218-PF, ZDEG-PT-32-162-PF, ZDEG-PT-32-202-PF, ZDEG-PT-34-159-PF, ZDEG-PT-34-199-PF, ZDEG-PT-36-159-PF, ZDEG-PT-36-199-PF, ZDEG-PT-38-154-PF, ZDEG-PT-38-204-PF, ZDEG-PT-40-160-PF, ZDEG-PT-40-210-PF, ZDEG-PT-42-160-PF, ZDEG-PT-42-210-PF, ZDEG-PT-32-24-158-PF, ZDEG-PT-32-24-196-PF, ZDEG-PT-34-26-156-PF, ZDEG-PT-34-26-194-PF, ZDEG-PT-36-28-159-PF, ZDEG-PT-36-28-199-PF, ZDEG-PT-38-30-159-PF, ZDEG-PT-38-30-199-PF, ZDEG-PT-40-32-165-PF, ZDEG-PT-40-32-205-PF, ZDEG-PT-42-34-160-PF, ZDEG-PT-42-34-210-PF)
Registration date
April 26, 2023
Expiry date
June 27, 2028
Source update date
May 02, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Stent/Grafts, Vascular, Aortic
Published parties
Registrant / registration holder
Cook Asia Ltd
Official description

Stent/Grafts, Vascular, Aortic

Additional source fields
AMD nomenclature code
20453
Local responsible person phone
34721688
Published manufacturer address
Sandet 6, DK 4632 Bjaeverskov, Denmark
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.