Taiwan FDA registration 60ffb75f74d229c9e6f09244c866c832

SONOLITH I-Sys Extracorporeal Shock Wave Lithotripter

TW: 蘇諾里仕埃西司體外震波碎石機

Taiwan·Risk Class 2·MD·EDAP TMS FRANCE S.A.·Registered May 11, 2011 – May 11, 2026Expired

Registration details

Analysis ID: 60ffb75f74d229c9e6f09244c866c832
License Form: Department of Health Medical Device Import No. 022386
Customs Code: DHAS0602238602

Company information

Manufacturer: EDAP TMS FRANCE S.A.
Manufacturer Country: France
Authorized Representative: LITHO MED TRADING CO., LTD.

Product details

Intended Use: For details, it is Chinese approved copy of the imitation order
Product Type (Level 1): H Gastroenterology-urology devices
Product Type (Level 2): H5990 Extracorporeal shock wave lithotripsy
Import Information: Imported from abroad; Consent must be obtained for each input (each input must be backed by the consent of the Atomic Energy Commission); The use of this equipment shall comply with the "Administrative Measures for the Implementation or Use of Specific Medical Technical Examination and Inspection Medical Equipment"

Dates and status

Registration Date: May 11, 2011
Expiry Date: May 11, 2026

About this record

Access comprehensive regulatory information for SONOLITH I-Sys Extracorporeal Shock Wave Lithotripter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 60ffb75f74d229c9e6f09244c866c832 and manufactured by EDAP TMS FRANCE S.A.. The authorized representative in Taiwan is LITHO MED TRADING CO., LTD..

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