Taiwan FDA registration 61a0446d34d991b05eacc6aa671471af
“BIOTRONIK” Astron Peripheral Self-Expanding Nitinol Stent System
TW: “百多力”艾思壯自擴型周邊鎳鈦合金支架系統
Registration details
- Analysis ID
- 61a0446d34d991b05eacc6aa671471af
- License Form
- Ministry of Health Medical Device Import No. 032781
- Customs Code
- DHA05603278109
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)
- 0001
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 02, 2019
- Expiry Date
- Aug 02, 2024
About this record
Access comprehensive regulatory information for “BIOTRONIK” Astron Peripheral Self-Expanding Nitinol Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 61a0446d34d991b05eacc6aa671471af and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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