120461
IV
Expired.
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
็ขๅ่ณ่จ๏ผ ๅฏผ่็บฟใๆคๅ ฅๅผๅฟ่่ตทๆๅจใๅฟๅ ่
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
Expired.
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
August 28, 2015
Expiry Date
January 09, 2018
Product Models
Safio S 53, Safio S 60
่จ่ฒๅฅฅ S 53, ่จ่ฒๅฅฅ S 60