Taiwan FDA registration 6af426f8a5447713d67509cf462fe908
“Spectranetics” AngioSculpt PTCA Scoring Balloon Catheter
TW: “史特勞斯”安卓史考特冠狀動脈血管網狀氣球導管
Taiwan·Risk Class 3·MD·Spectranetics Corporation·Registered Aug 13, 2018 – Aug 13, 2028ActiveRegistration details
- Analysis ID
- 6af426f8a5447713d67509cf462fe908
- License Form
- Ministry of Health Medical Device Import No. 030826
- Customs Code
- DHA05603082608
Company information
- Manufacturer
- Spectranetics Corporation
- Manufacturer Country
- United States
- Authorized Representative
- LORION ENTERPRISES INC.
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)
- E0005 Percutaneous puncture of the coronary ductus
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 13, 2018
- Expiry Date
- Aug 13, 2028
About this record
Access comprehensive regulatory information for “Spectranetics” AngioSculpt PTCA Scoring Balloon Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6af426f8a5447713d67509cf462fe908 and manufactured by Spectranetics Corporation. The authorized representative in Taiwan is LORION ENTERPRISES INC..
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