Taiwan FDA registration 0dc3cd6b1661e69d40cdaaf9a84e6f61
"Parkson" Baimecui release coronary artery stent system
TW: “柏盛”拜美翠釋放型冠狀動脈支架系統
Taiwan·Risk Class 3·BIOSENSORS EUROPE SA·Registered Aug 04, 2010 – Aug 04, 2015CancelledRegistration details
- Analysis ID
- 0dc3cd6b1661e69d40cdaaf9a84e6f61
- Customs Code
- DHA00602122807
Company information
- Manufacturer
- BIOSENSORS EUROPE SA
- Manufacturer Country
- Switzerland
- Authorized Representative
- KINGDOM EAST ENTERPRISE CO., LTD.
Product details
- Intended Use
- It is suitable for patients with symptomatic ischemic heart disease to reduce in-stent restenosis and treat symptomatic primary coronary artery stenosis, with a reference diameter of 2.25 mm to 4.0 mm.
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E.0001 Cardiovascular stents
- Import Information
- import
Dates and status
- Registration Date
- Aug 04, 2010
- Expiry Date
- Aug 04, 2015
- Cancellation Date
- Aug 09, 2018
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Parkson" Baimecui release coronary artery 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 0dc3cd6b1661e69d40cdaaf9a84e6f61 and manufactured by BIOSENSORS EUROPE SA. The authorized representative in Taiwan is KINGDOM EAST ENTERPRISE CO., LTD..
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