Taiwan FDA registration 8fba8fbecc2fcb45b234613b10178b5c
“BIOTRONIK” Passeo-35 Xeo Peripheral Dilatation Catheter
TW: “百多力” 新帕希爾35周邊擴張導管
Taiwan·Risk Class 2·MD·BIOTRONIK AG·Registered Jul 16, 2021 – May 09, 2024ExpiredRegistration details
- Analysis ID
- 8fba8fbecc2fcb45b234613b10178b5c
- License Form
- Ministry of Health Medical Device Import No. 034760
- Customs Code
- DHA05603476001
Company information
- Manufacturer
- BIOTRONIK AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E1250 Percutaneous catheter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 16, 2021
- Expiry Date
- May 09, 2024
About this record
Access comprehensive regulatory information for “BIOTRONIK” Passeo-35 Xeo Peripheral Dilatation Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8fba8fbecc2fcb45b234613b10178b5c and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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