Taiwan FDA registration 09bf7708156891c352647022b5fe26d5
"Sefir" artificial urethral sphincter
TW: “賽菲爾”人工尿道括約肌
Taiwan·Risk Class 3·ZEPHYR Surgical Implants Sàrl;; Statice Sante·Registered Aug 19, 2014 – Aug 19, 2019CancelledRegistration details
- Analysis ID
- 09bf7708156891c352647022b5fe26d5
- Customs Code
- DHA05602647707
Company information
- Manufacturer
- ZEPHYR Surgical Implants Sàrl;; Statice Sante
- Manufacturer Country
- France;;Switzerland
- Authorized Representative
- SHAWHAN BIOMEDICAL 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.5280 Implantable Mechanical/Compressed Urinary Homemade Devices
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- Aug 19, 2014
- Expiry Date
- Aug 19, 2019
- Cancellation Date
- Aug 05, 2022
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Sefir" artificial urethral sphincter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 09bf7708156891c352647022b5fe26d5 and manufactured by ZEPHYR Surgical Implants Sàrl;; Statice Sante. The authorized representative in Taiwan is SHAWHAN BIOMEDICAL CO., LTD..
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