230313
IV
current
Defibrillator/Pacemakers, Implantable้ค้ขคๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ
This profile provides complete Hong Kong MDACS registration information for Defibrillator/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/Pacemakers, Implantable
็ขๅ่ณ่จ๏ผ ้ค้ขคๅจ/่ตทๆๅจ,ๆคๅ ฅๅผ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17989
Product Code Detail
17989 Defibrillator/Pacemakers, Implantable
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Woermannkehre 1, 12359 Berlin, GERMANY
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
September 14, 2023
Expiry Date
September 14, 2028
Product Models
Acticor 7 VR-T (429526), Acticor 7 VR-T DX (429525), Acticor 7 DR-T (429524), Acticor 7 HF-T (429523), Acticor 7 HF-T QP (429522)
Acticor 7 VR-T (429526), Acticor 7 VR-T DX (429525), Acticor 7 DR-T (429524), Acticor 7 HF-T (429523), Acticor 7 HF-T QP (429522)