Taiwan FDA registration 0e010faa1ce38d77f6343734681cdda2
“AR Baltic”ELUTAX 3 Paclitaxel eluting Balloon Catheter
TW: “艾爾貝提克”伊路特斯三紫杉醇塗藥球囊導管
Taiwan·Risk Class 2·MD·AR Baltic Medical UAB·Registered Oct 06, 2022 – Oct 06, 2027ActiveRegistration details
- Analysis ID
- 0e010faa1ce38d77f6343734681cdda2
- License Form
- Ministry of Health Medical Device Import No. 034625
- Customs Code
- DHA05603462505
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)
- E1250 Percutaneous catheter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 06, 2022
- Expiry Date
- Oct 06, 2027
About this record
Access comprehensive regulatory information for “AR Baltic”ELUTAX 3 Paclitaxel eluting 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 0e010faa1ce38d77f6343734681cdda2 and manufactured by AR Baltic Medical UAB. The authorized representative in Taiwan is WIN CHAMP MEDICAL CO., LTD..
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