240372
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
็ขๅ่ณ่จ๏ผ ้ค้ขคๅจ/ๅฟ่ๅคๅพๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ,ๅๅๆญฅ
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
Brand
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
ๅฟ่ๅๅๆญฅๆฒป็้ค้ขคๅจ (CRT-D)
Manufacturer (่ฃฝ้ ๅ)
Abbott Medical
Abbott Medical
United States
็พๅฝ
15900 Valley View Court, Sylmar, CA 91342, USA
15900ๅฑฑ่ฐทๆฏ่งๆณ้ข,่ฅฟๅฐ้ฉฌ,CA 91342,็พๅฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พๅฝ้
ๅนๅป็็จๅ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
29967688
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
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)