Taiwan FDA registration cb6b849abda7a6bf15e3405a126c4be3
“AR Baltic” ELUTAX 3 Paclitaxel eluting OTW Balloon-Catheter
TW: “艾爾貝提克” 伊路特斯三紫杉醇塗藥周邊球囊導管
Taiwan·Risk Class 2·MD·AR Baltic Medical UAB·Registered Aug 17, 2023 – Aug 17, 2028ActiveRegistration details
- Analysis ID
- cb6b849abda7a6bf15e3405a126c4be3
- License Form
- Ministry of Health Medical Device Import No. 036582
- Customs Code
- DHA05603658200
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
- Aug 17, 2023
- Expiry Date
- Aug 17, 2028
About this record
Access comprehensive regulatory information for “AR Baltic” ELUTAX 3 Paclitaxel eluting OTW 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 cb6b849abda7a6bf15e3405a126c4be3 and manufactured by AR Baltic Medical UAB. The authorized representative in Taiwan is WIN CHAMP MEDICAL CO., LTD..
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