Medical Device Division · registration 180136Active

St. Jude Medical

Name: St. Jude Medical — Medical Device Division 180136
Creator: St. Jude Medical Cardiac Rhythm Management Division
Keywords: St. Jude Medical, St. Jude Medical, 180136, Electrocardiographs, Ambulatory, Loop-Recording, Implantable, Medical Device Division

Hong KongElectrocardiographs, Ambulatory, Loop-Recording, ImplantableClass IVSt. Jude Medical Cardiac Rhythm Management Division

Verified

Official record identity

MDACS listing number: 180136
Model name: Confirm Rx (DM3500), Confirm Rx Incision Tool (DM3520), Confirm Insertion Tool (DM3510)
Registration date: January 04, 2023
Expiry date: May 12, 2028
Source update date: October 25, 2024
Status: Active

Classification

Risk class: Class IV
Published category: Electrocardiographs, Ambulatory, Loop-Recording, Implantable

Published parties

Registrant / registration holder: Abbott Medical (Hong Kong) Limited
Manufacturer: St. Jude Medical Cardiac Rhythm Management Division

Official description

Electrocardiographs, Ambulatory, Loop-Recording, Implantable

Additional source fields

AMD nomenclature code: 24177
Traditional Chinese local responsible person: 美國雅培醫療用品(香港)有限公司
Local responsible person phone: 29967688
Published manufacturer address: 15900 Valley View Court, Sylmar, CA 91342, USA
Revision number: c

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.