Taiwan FDA registration 8f4ced1cce22ad82a03175b5c0399da1
"Idaipu" high-focus ultrasound therapy system
TW: “伊岱普”高聚焦超音波治療系統
Taiwan·Risk Class 3·EDAP TMS FRANCE·Registered Mar 17, 2020 – Mar 17, 2029ActiveRegistration details
- Analysis ID
- 8f4ced1cce22ad82a03175b5c0399da1
- Customs Code
- DHA00601996500
Company information
- Manufacturer
- EDAP TMS FRANCE
- Manufacturer Country
- France
- Authorized Representative
- JIANHE BIO-MEDICAL LTD.
Product details
- Intended Use
- 1. For patients with localized prostate cancer (T1, T2 type), this treatment system can be used as a priority treatment for patients who are not suitable for surgery. 2. For patients who still have local recurrence or residual lesions after external radiotherapy or prostate eradication surgery, multiple treatment options can be provided.
- Product Type (Level 1)
- H Gastroenterology and urology
- Import Information
- import
Dates and status
- Registration Date
- Mar 17, 2020
- Expiry Date
- Mar 17, 2029
About this record
Access comprehensive regulatory information for "Idaipu" high-focus ultrasound therapy system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8f4ced1cce22ad82a03175b5c0399da1 and manufactured by EDAP TMS FRANCE. The authorized representative in Taiwan is JIANHE BIO-MEDICAL LTD..
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