190058
IV
current
Leads, Implantable Defibrillator/Cardiac Pacemakerๅฏผ็บฟ,ๆคๅ ฅๅผ้ค้ขคๅจ/ๅฟ่่ตทๆๅจ
This profile provides complete Hong Kong MDACS registration information for Leads, Implantable Defibrillator/Cardiac Pacemaker. 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/Cardiac Pacemaker
็ขๅ่ณ่จ๏ผ ๅฏผ็บฟ,ๆคๅ ฅๅผ้ค้ขคๅจ/ๅฟ่่ตทๆๅจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17964
Product Code Detail
17964 Leads, Implantable Defibrillator/Cardiac Pacemaker
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
December 08, 2023
Expiry Date
February 25, 2029
Product Models
Plexa ProMRI DF-1 SD 65/16, Plexa ProMRI DF-1 SD 65/18, Plexa ProMRI DF-1 SD 75/18, Plexa ProMRI DF-1 S 65, Plexa ProMRI DF-1 S 75, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI DF-1 S DX 65/17
Plexa ProMRI DF-1 SD 65/16, Plexa ProMRI DF-1 SD 65/18, Plexa ProMRI DF-1 SD 75/18, Plexa ProMRI DF-1 S 65, Plexa ProMRI DF-1 S 75, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI DF-1 S DX 65/17