Taiwan FDA registration 84df073521bb3c6ec1b85141ec12faec
“BIOTRONIK” Pro-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System
TW: “百多力”普凱能鈷鉻冠狀動脈支架系統
Registration details
- Analysis ID
- 84df073521bb3c6ec1b85141ec12faec
- License Form
- Ministry of Health Medical Device Import No. 027430
- Customs Code
- DHA05602743002
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)
- E0001 Cardiovascular stents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 24, 2015
- Expiry Date
- Jun 24, 2025
About this record
Access comprehensive regulatory information for “BIOTRONIK” Pro-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 84df073521bb3c6ec1b85141ec12faec and manufactured by BIOTRONIK AG. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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