Taiwan FDA registration 231898b51f95c2490ab44f8bcf34aeb1
“Uroplasty” Urgent PC Neuromodulation System and accessories
TW: “優羅普拉斯提”經皮急迫性失禁電刺激器及附件
Registration details
- Analysis ID
- 231898b51f95c2490ab44f8bcf34aeb1
- License Form
- Ministry of Health Medical Device Import No. 032713
- Customs Code
- DHA05603271305
Company information
- Manufacturer
- Uroplasty, LLC
- Manufacturer Country
- United States
- Authorized Representative
- GIANT BOAT CO., LTD.
Product details
- Intended Use
- This product can be combined with its needle electrode kit for percutaneous (needle prick) tibial nerve stimulation; PTNS), and to treat patients diagnosed by a physician with acute urination, frequent urination, and urge incontinence.
- Product Type (Level 1)
- H Gastroenterology-urology devices
- Product Type (Level 2)
- H5310 Non-implantable peripheral electronic urination homemade device
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 13, 2019
- Expiry Date
- Jun 13, 2024
About this record
Access comprehensive regulatory information for “Uroplasty” Urgent PC Neuromodulation System and accessories in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 231898b51f95c2490ab44f8bcf34aeb1 and manufactured by Uroplasty, LLC. The authorized representative in Taiwan is GIANT BOAT CO., LTD..
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