130441
Defibrillator/Cardioverter/Pacemakers, Implantable
除颤器/心脏转复器/起搏器,植入式
St. Jude Medical Cardiac Rhythm Management Division·IV·Hong Kong MDACS·Registered July 26, 2023
Device overview
- Risk class
- IV
- Product code
- 18504
- State
- current
- Status
- N/A
- Product code detail
- 18504 Defibrillator/Cardioverter/Pacemakers, Implantable
Manufacturer (製造商)
- Name
- St. Jude Medical Cardiac Rhythm Management DivisionBoston Scientific
- Country
- United States美国
- Address
- 15900 Valley View Court, Sylmar, CA 91342, USA15900山谷景观法院,西尔马,CA 91342,美国
Authorised representative (AR)
- Name
- Abbott Medical (Hong Kong) Limited美国雅培医疗用品(香港)有限公司
- Phone
- 29967688
Regulatory timeline
- Registration date
- July 26, 2023
- Expiry date
- December 13, 2028
Product models
Fortify Assura VR (CD1359‐40C, CD1359‐40QC), Fortify Assura DR (CD2359‐40C, CD2359‐40QC), Ellipse VR (CD1377‐36C, CD1377‐36QC), Ellipse DR (CD2377‐36C, CD2377‐36QC)
Fortify Assura VR (CD1359-40C, CD1359-40QC), Fortify Assura DR (CD2359-40C, CD2359‐40QC), Ellipse VR (CD1377‐36C, CD1377‐36QC), Ellipse DR (CD2377‐36C, CD2377-36QC)
About this record
This profile provides complete Hong Kong MDACS registration information for Defibrillator/Cardioverter/Pacemakers, Implantable. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Defibrillator/Cardioverter/Pacemakers, Implantable
產品資訊： 除颤器/心脏转复器/起搏器,植入式