130440
IV
current
Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization้ค้ขคๅจ/ๅฟ่ๅคๅพๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ,ๅๅๆญฅ
This profile provides complete Hong Kong MDACS registration information for Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization. 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, Resynchronization
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20376
Product Code Detail
20376 Defibrillator/Cardioverter/Pacemakers, Implantable, Resynchronization
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
St. Jude Medical Cardiac Rhythm Management Division
Boston Scientific
United States
็พๅฝ
15900 Valley View Court, Sylmar, CA 91342, USA
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Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พๅฝ้
ๅนๅป็็จๅ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
29967688
Regulatory Timeline
Registration Date
October 26, 2023
Expiry Date
December 13, 2028
Product Models
Unify Assura (CD3361-40C, CD3361-40QC), Quadra Assura (CD3367-40C, CD3367-40QC), Quadra Assura MP (CD3371-40C, CD3371-40QC)
Unify Assura (CD3361-40C, CD3361-40QC), Quadra Assura (CD3367-40C, CD3367-40QC), Quadra Assura MP (CD3371-40C, CD3371-40QC)