Taiwan FDA registration 4e2afd60a03ee730dc82fa36a3315c91
“BIOTRONIK” Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter
TW: “百多力”帕西歐樂思紫杉醇釋放周邊血管氣球擴張導管
Taiwan·Risk Class 2·MD·BIOTRONIK AG·Registered May 17, 2016 – May 17, 2026ExpiredRegistration details
- Analysis ID
- 4e2afd60a03ee730dc82fa36a3315c91
- License Form
- Ministry of Health Medical Device Import No. 028535
- Customs Code
- DHA05602853505
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)
- E1250 Percutaneous catheter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 17, 2016
- Expiry Date
- May 17, 2026
About this record
Access comprehensive regulatory information for “BIOTRONIK” Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4e2afd60a03ee730dc82fa36a3315c91 and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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