240351
Pacemakers, Cardiac, Implantable
心脏起搏器,心脏,植入式
BIOTRONIK SE & Co. KG·IV·Hong Kong MDACS·Registered August 29, 2024
Device overview
- Risk class
- IV
- Product code
- 12913
- State
- current
- Status
- N/A
- Product code detail
- 12913 Pacemakers, Cardiac, Implantable
Manufacturer (製造商)
- Name
- BIOTRONIK SE & Co. KGBiotronik Ag
- 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
- August 29, 2024
- Expiry date
- August 28, 2029
Product models
Amvia Sky SR-T, Amvia Sky DR-T, Amvia Sky HF-T, Amvia Sky HF-T QP, Amvia Edge SR-T, Amvia Edge DR-T, Amvia Edge HF-T QP
Amvia Sky SR-T, Amvia Sky DR-T, Amvia Sky HF-T, Amvia Sky HF-T QP, Amvia Edge SR-T, Amvia Edge DR-T, Amvia Edge HF-T QP
About this record
This profile provides complete Hong Kong MDACS registration information for Pacemakers, Cardiac, Implantable. 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: Pacemakers, Cardiac, Implantable
產品資訊： 心脏起搏器,心脏,植入式