Taiwan FDA registration f84bdbe97ecd4bc345a06072799aabf5
“BIOTRONIK” Orsiro Sirolimus Eluting Coronary Stent System
TW: “百多力”歐禧樂西羅莫司冠狀動脈塗藥支架系統
Registration details
- Analysis ID
- f84bdbe97ecd4bc345a06072799aabf5
- License Form
- Ministry of Health Medical Device Import No. 025217
- Customs Code
- DHA05602521702
Company information
- Manufacturer
- BIOTRONIK AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 31, 2013
- Expiry Date
- Jul 31, 2028
About this record
Access comprehensive regulatory information for “BIOTRONIK” Orsiro Sirolimus Eluting Coronary Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number f84bdbe97ecd4bc345a06072799aabf5 and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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