200186
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 April 18, 2024
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
- April 18, 2024
- Expiry date
- June 23, 2025
Product models
Plexa ProMRI S 65 (402266), Plexa ProMRI S 75 (402267), Plexa ProMRI SD 65/16 (402262), Plexa ProMRI SD 65/18 (402263), Plexa ProMRI SD 75/18 (402264)
Plexa ProMRI S 65 (402266)、Plexa ProMRI S 75 (402267)、Plexa ProMRI SD 65/16 (402262)、Plexa ProMRI SD 65/18 (402263)、Plexa ProMRI SD 75/18 (402264)
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