180445
IV
current
Leads, Implantable Cardiac Pacemaker, Endocardialๅฏผ่็บฟใๆคๅ ฅๅผๅฟ่่ตทๆๅจใๅฟๅ ่
This profile provides complete Hong Kong MDACS registration information for Leads, Implantable Cardiac Pacemaker, Endocardial. 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 Cardiac Pacemaker, Endocardial
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
12900
Product Code Detail
12900 Leads, Implantable Cardiac Pacemaker, Endocardial
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Germany
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Woermannkehre 1, 12359 Berlin, Germany
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
October 15, 2024
Expiry Date
November 09, 2028
Product Models
Sentus ProMRI OTW QP L-75/49, Sentus ProMRI OTW QP L-85/49, Sentus ProMRI OTW QP L-95/49, Sentus ProMRI OTW QP S-75/49, Sentus ProMRI OTW QP S-85/49, Sentus ProMRI OTW QP S-95/49
Sentus ProMRI OTW QP L-75/49, Sentus ProMRI OTW QP L-85/49, Sentus ProMRI OTW QP L-95/49, Sentus ProMRI OTW QP S-75/49, Sentus ProMRI OTW QP S-85/49, Sentus ProMRI OTW QP S-95/49