Taiwan FDA registration 86201ba6b86793abe69343d21cea6fde
“BIOTRONIK” PK Papyrus Covered Coronary Stent System
TW: “百多力”帕碧若思覆膜式冠狀動脈支架
Taiwan·Risk Class 3·MD·BIOTRONIK AG·Registered Mar 30, 2016 – Mar 30, 2026ExpiredRegistration details
- Analysis ID
- 86201ba6b86793abe69343d21cea6fde
- License Form
- Ministry of Health Medical Device Import No. 028391
- Customs Code
- DHA05602839107
Company information
- Manufacturer
- BIOTRONIK AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- This product is used to treat acute coronary artery perforation.
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 30, 2016
- Expiry Date
- Mar 30, 2026
About this record
Access comprehensive regulatory information for “BIOTRONIK” PK Papyrus Covered 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 86201ba6b86793abe69343d21cea6fde and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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