220022
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
Manufacturer (่ฃฝ้ ๅ)
St. Jude Medical Cardiac Rhythm Management Division
Boston Scientific
United States
็พๅฝ
15900 Valley View Court, Sylmar CA 91342, USA
15900ๅฑฑ่ฐทๆฏ่งๆณ้ข, ่ฅฟๅฐ้ฉฌCA 91342, ็พๅฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พๅฝ้
ๅนๅป็็จๅ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
29967688
Regulatory Timeline
Registration Date
January 20, 2022
Expiry Date
January 20, 2027
Product Models
Avant VR (CDVRA700Q), Gallant VR (CDVRA500Q), Entrant VR (CDVRA300Q), Neutrino NxT VR (CDVRA800Q, CDVRA600Q), Avant DR (CDDRA700Q), Gallant DR (CDDRA500Q), Entrant DR (CDDRA300Q), Neutrino NxT DR (CDDRA800Q, CDDRA600Q), Avant HF (CDHFA700Q), Gallant HF (CDHFA500Q), Entrant HF (CDHFA300Q), Neutrino NxT HF (CDHFA800Q, CDHFA600Q)
Front VR (CDVRA700Q), Gallant VR (CDVRA500Q), Enterrant VR (CDVRA300Q), Neutrino NxT VR (CDVRA800Q, CDVRA600Q), Front DR (CDDRA700Q), Gallant DR (CDDRA500Q), Enterrant DR (CDDRA300Q), Neutrino NxT DR (CDDRA800Q, CDDRA600Q), Front HF (CDHFA700Q), Gallant HF (CDHFA500Q), Inbound HF (CDHFA300Q), Neutrino NxT HF (CDHFA800Q, CDHFA600Q)

