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Youle diurethral dilation system - Taiwan Registration e67ccb5cc852b30cb32c213c321986f3

Access comprehensive regulatory information for Youle diurethral dilation system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e67ccb5cc852b30cb32c213c321986f3 and manufactured by NeoTract, Inc.,;; Hudson Respiratory Care Tecate S.de R.L.de C.V.(A Teleflex Medical Company). The authorized representative in Taiwan is TELEFLEX MEDICAL TAIWAN LTD..

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e67ccb5cc852b30cb32c213c321986f3
Registration Details
Taiwan FDA Registration: e67ccb5cc852b30cb32c213c321986f3
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Device Details

Youle diurethral dilation system
TW: ๅ„ชๆจ‚ๅˆฉๅฐฟ้“ๆ“ดๅผต็ณป็ตฑ
Risk Class 2

Registration Details

e67ccb5cc852b30cb32c213c321986f3

DHA05603391509

Product Details

This product is suitable for the treatment of men aged 50 or above due to benign prostate hyperplasia caused by obstruction of urine flow. Performance changes and labels, instructions or packaging changes, as detailed in the approved Chinese instructions (the original approved labels, instructions or packaging on September 18, 109 will be recycled and scrapped).

H Gastroenterology and urology

H.5220 ็ต่…ธ็Œๆฒ–็ณป็ตฑ

Input;; Contract manufacturing

Dates and Status

Sep 01, 2020

Sep 01, 2025