Taiwan FDA registration aee06d6c04b118ba80fbe5f0ed959c7f
“BIOTRONIK” Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter
TW: “百多力”潘德拉紫杉醇釋放氣球導管
Taiwan·Risk Class 2·MD·BIOTRONIK AG·Registered May 09, 2016 – May 09, 2026ExpiredRegistration details
- Analysis ID
- aee06d6c04b118ba80fbe5f0ed959c7f
- License Form
- Ministry of Health Medical Device Import No. 028529
- Customs Code
- DHA05602852900
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)
- E0005 Percutaneous puncture of the coronary ductus
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 09, 2016
- Expiry Date
- May 09, 2026
About this record
Access comprehensive regulatory information for “BIOTRONIK” Pantera Lux Paclitaxel Releasing PTCA 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 aee06d6c04b118ba80fbe5f0ed959c7f and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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