Taiwan FDA registration e67ccb5cc852b30cb32c213c321986f3

Youle diurethral dilation system

TW: 優樂利尿道擴張系統

Taiwan·Risk Class 2·NeoTract, Inc.,;; Hudson Respiratory Care Tecate S.de R.L.de C.V.(A Teleflex Medical Company)·Registered Sep 01, 2020 – Sep 01, 2025Expired

Registration details

Analysis ID: e67ccb5cc852b30cb32c213c321986f3
Customs Code: DHA05603391509

Company information

Manufacturer: NeoTract, Inc.,;; Hudson Respiratory Care Tecate S.de R.L.de C.V.(A Teleflex Medical Company)
Manufacturer Country: Mexico;;United States
Authorized Representative: TELEFLEX MEDICAL TAIWAN LTD.

Product details

Intended Use: 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).
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.5220 結腸灌沖系統
Import Information: Input;; Contract manufacturing

Dates and status

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

About this record

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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