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
Taiwan flagTaiwan·Risk Class 2·MD·Uroplasty, LLC·Registered Jun 13, 2019 – Jun 13, 2024Expired
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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