190058
Leads, Implantable Defibrillator/Cardiac Pacemaker
导线,植入式除颤器/心脏起搏器
BIOTRONIK SE & Co. KG·IV·Hong Kong MDACS·Registered December 08, 2023
Device overview
- Risk class
- IV
- Product code
- 17964
- State
- current
- Status
- N/A
- Product code detail
- 17964 Leads, Implantable Defibrillator/Cardiac Pacemaker
Manufacturer (製造商)
- Name
- BIOTRONIK SE & Co. KGBiotronik Ag
- Country
- Germany德国
- Address
- Woermannkehre 1, 12359 Berlin, GermanyWoermannkehre 1, 12359 柏林, 德国
Authorised representative (AR)
- Name
- Biotronik Hong Kong Limited百多力香港有限公司
- Phone
- 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
About this record
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
產品資訊: 导线,植入式除颤器/心脏起搏器