230127
IV
current
Leads, Implantable Defibrillator/Pacemaker, Resynchronizationๅฏผ่็บฟใๆคๅ ฅๅผ้ค้ขคๅจ/่ตทๆๅจใๅๅๆญฅ
This profile provides complete Hong Kong MDACS registration information for Leads, Implantable Defibrillator/Pacemaker, 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: Leads, Implantable Defibrillator/Pacemaker, Resynchronization
็ขๅ่ณ่จ๏ผ ๅฏผ่็บฟใๆคๅ ฅๅผ้ค้ขคๅจ/่ตทๆๅจใๅๅๆญฅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20377
Product Code Detail
20377 Leads, Implantable Defibrillator/Pacemaker, Resynchronization
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Germany
ๅพทๅฝ
Woermannkehre 1, 12359 Berlin, Germany
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
April 06, 2023
Expiry Date
April 06, 2028
Product Models
Sentus ProMRI OTW QP (L-75, L-85, L-95, S-75, S-85, S-95)
Sentus ProMRI OTW QP (L-75, L-85, L-95, S-75, S-85, S-95)