180136
IV
current
Electrocardiographs, Ambulatory, Loop-Recording, Implantableๅฟ็ตๅพไปช,ๅจๆ,ๅพช็ฏ่ฎฐๅฝ,ๆคๅ ฅๅผ
This profile provides complete Hong Kong MDACS registration information for Electrocardiographs, Ambulatory, Loop-Recording, 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: Electrocardiographs, Ambulatory, Loop-Recording, Implantable
็ขๅ่ณ่จ๏ผ ๅฟ็ตๅพไปช,ๅจๆ,ๅพช็ฏ่ฎฐๅฝ,ๆคๅ ฅๅผ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
24177
Product Code Detail
24177 Electrocardiographs, Ambulatory, Loop-Recording, 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
January 04, 2023
Expiry Date
May 12, 2028
Product Models
Confirm Rx (DM3500), Confirm Rx Incision Tool (DM3520), Confirm Insertion Tool (DM3510)
็กฎ่ฎคๆฅๆถ (DM3500), ็กฎ่ฎคๆฅๆถๅๅฃๅทฅๅ
ท (DM3520), ็กฎ่ฎคๆๅ
ฅๅทฅๅ
ท (DM3510)