Taiwan FDA registration a45d7016217d8a5a1bf7a64b1af638eb
“Biotronik” Passeo-18 PTA balloon catheter
TW: “百多力”帕希爾18周邊血管氣球擴張導管
Registration details
- Analysis ID
- a45d7016217d8a5a1bf7a64b1af638eb
- License Form
- Ministry of Health Medical Device Import No. 025804
- Customs Code
- DHA05602580404
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
- Feb 06, 2014
- Expiry Date
- Feb 06, 2024
About this record
Access comprehensive regulatory information for “Biotronik” Passeo-18 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 a45d7016217d8a5a1bf7a64b1af638eb and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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