130441
IV
current
Defibrillator/Cardioverter/Pacemakers, Implantable้ค้ขคๅจ/ๅฟ่่ฝฌๅคๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ
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
็ขๅ่ณ่จ๏ผ ้ค้ขคๅจ/ๅฟ่่ฝฌๅคๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18504
Product Code Detail
18504 Defibrillator/Cardioverter/Pacemakers, Implantable
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
15900ๅฑฑ่ฐทๆฏ่งๆณ้ข,่ฅฟๅฐ้ฉฌ,CA 91342,็พๅฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พๅฝ้
ๅนๅป็็จๅ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
29967688
Regulatory Timeline
Registration Date
July 26, 2023
Expiry Date
December 13, 2028
Product Models
Fortify Assura VR (CD1359โ40C, CD1359โ40QC), Fortify Assura DR (CD2359โ40C, CD2359โ40QC), Ellipse VR (CD1377โ36C, CD1377โ36QC), Ellipse DR (CD2377โ36C, CD2377โ36QC)
Fortify Assura VR (CD1359-40C, CD1359-40QC), Fortify Assura DR (CD2359-40C, CD2359โ40QC), Ellipse VR (CD1377โ36C, CD1377โ36QC), Ellipse DR (CD2377โ36C, CD2377-36QC)