220093
Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
导管、血管、血管成形术、球囊、冠状动脉、药物输送
Biotronik AG·IV·Hong Kong MDACS·Registered March 14, 2022
Device overview
- Risk class
- IV
- Product code
- 18645
- State
- current
- Status
- N/A
- Product code detail
- 18645 Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
Manufacturer (製造商)
- Name
- Biotronik AGBiotronik Ag
- Country
- Switzerland瑞士
- Address
- Ackerstrasse 6, 8180 Bulach, SwitzerlandAckerstrasse 6, 8180 布拉赫, 瑞士
Authorised representative (AR)
- Name
- Biotronik Hong Kong Limited百多力香港有限公司
- Phone
- 31904500
Regulatory timeline
- Registration date
- March 14, 2022
- Expiry date
- March 14, 2027
Product models
Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter (365110, 365120, 365125, 365130, 365135, 365111, 365121, 365126, 365131, 365136, 365112, 365122, 365127, 365132, 365137, 365113, 365123, 365128, 365133, 365138, 365114, 365124, 365129, 365134, 365139)
Pantera lux紫杉醇释放PTCA球囊导管(365110,365120,365125,365130,365135,365111,365121,365126,365131,365136,365112,365122,365127,365132,365137,365113,365123,365128,365133,365138,365114,365124,365129,365134,365139)
About this record
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery. 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: Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
產品資訊： 导管、血管、血管成形术、球囊、冠状动脉、药物输送