Taiwan FDA registration e91fb7a72dbcfd28d7d9a0d048d13f79
“BIOTRONIK” Pantera Leo Fast-Exchange PTCA Catheter
TW: “百多力”帕得拉禮歐快速交換式冠狀動脈導管
Registration details
- Analysis ID
- e91fb7a72dbcfd28d7d9a0d048d13f79
- License Form
- Ministry of Health Medical Device Import No. 027597
- Customs Code
- DHA05602759709
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
- Aug 18, 2015
- Expiry Date
- Aug 18, 2025
About this record
Access comprehensive regulatory information for “BIOTRONIK” Pantera Leo Fast-Exchange PTCA Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e91fb7a72dbcfd28d7d9a0d048d13f79 and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices