Taiwan FDA registration 0f2d6d9d682f9020da16259b5bc02bc3
"Sunolis" extracorporeal shock wave lithotripsy machine
TW: “蘇諾里仕”體外震波碎石機
Registration details
- Analysis ID
- 0f2d6d9d682f9020da16259b5bc02bc3
- Customs Code
- DHA00602134409
Company information
- Manufacturer
- EDAP TMS FRANCE S.A.
- Manufacturer Country
- France
- Authorized Representative
- LOTUS MEDITEK CO., LTD.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- H Gastroenterology and urology
- Product Type (Level 2)
- H.5990 體外震波碎石器
- Import Information
- The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". input
Dates and status
- Registration Date
- Sep 01, 2010
- Expiry Date
- Sep 01, 2015
- Cancellation Date
- Jun 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Sunolis" extracorporeal shock wave lithotripsy machine in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0f2d6d9d682f9020da16259b5bc02bc3 and manufactured by EDAP TMS FRANCE S.A.. The authorized representative in Taiwan is LOTUS MEDITEK CO., LTD..
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