Taiwan FDA registration 0315fb9b600d317c2ed23dc68cfc3817
“AR Baltic” ELUTAX 3 Paclitaxel coated Coronary Balloon Catheter
TW: “艾爾貝提克”伊路特斯三紫杉醇塗藥冠狀動脈球囊導管
Taiwan·Risk Class 2·MD·AR Baltic Medical UAB·Registered Jun 21, 2023 – Jun 21, 2028ActiveRegistration details
- Analysis ID
- 0315fb9b600d317c2ed23dc68cfc3817
- License Form
- Ministry of Health Medical Device Import No. 036555
- Customs Code
- DHA05603655507
Company information
- Manufacturer
- AR Baltic Medical UAB
- Manufacturer Country
- Lithuania
- Authorized Representative
- WIN CHAMP MEDICAL CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E0005 Percutaneous puncture of the coronary ductus
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 21, 2023
- Expiry Date
- Jun 21, 2028
About this record
Access comprehensive regulatory information for “AR Baltic” ELUTAX 3 Paclitaxel coated Coronary 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 0315fb9b600d317c2ed23dc68cfc3817 and manufactured by AR Baltic Medical UAB. The authorized representative in Taiwan is WIN CHAMP MEDICAL CO., LTD..
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