Taiwan FDA registration 59eea307f3269d54f17b4e7d68cbff4f

“Boston Scientific” Autolith Touch Bipolar Electrohydraulic Lithotripter

TW: “波士頓科技”電震波碎石儀

Taiwan·Risk Class 2·MD·Northgate Technologies, Inc.·Registered Jul 01, 2020 – Jul 01, 2025Expired

Registration details

Analysis ID: 59eea307f3269d54f17b4e7d68cbff4f
License Form: Ministry of Health Medical Device Import No. 033664
Customs Code: DHA05603366400

Company information

Manufacturer: Northgate Technologies, Inc.
Manufacturer Country: United States
Authorized Representative: Dutch Boston Technology Co., Ltd. Taiwan Branch

Product details

Intended Use: The purpose of this device is to use our bipolar disposable electric shock wave crushing probe for the lysis of biliary stones.
Product Type (Level 1): H Gastroenterology-urology devices
Product Type (Level 2): H4480 Electroshock wave lithotripsy instrument
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 01, 2020
Expiry Date: Jul 01, 2025

About this record

Access comprehensive regulatory information for “Boston Scientific” Autolith Touch Bipolar Electrohydraulic Lithotripter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 59eea307f3269d54f17b4e7d68cbff4f and manufactured by Northgate Technologies, Inc.. The authorized representative in Taiwan is Dutch Boston Technology Co., Ltd. Taiwan Branch.

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