Taiwan FDA registration 06fc2ab58bff465c4d9bdb82db27963d
"Exer" Catheter Fixation Device (Sterilized)
TW: "艾克瑟" 導管固定裝置(滅菌)
Taiwan·Risk Class 1·Bonte Biotechnology Co., Ltd. Yilan Plant 2·Registered Oct 23, 2024 – Oct 23, 2029ActiveRegistration details
- Analysis ID
- 06fc2ab58bff465c4d9bdb82db27963d
Company information
- Manufacturer
- Bonte Biotechnology Co., Ltd. Yilan Plant 2
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- BIOTEQUE CORPORATION
Product details
- Intended Use
- It is limited to the first level identification scope of the Intravascular Catheter Fixation Device (J.5210) of the Classification and Grading Management Measures for Medical Devices.
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.5210 血管內導管固定裝置
- Import Information
- 國產;; QMS/QSD
Dates and status
- Registration Date
- Oct 23, 2024
- Expiry Date
- Oct 23, 2029
About this record
Access comprehensive regulatory information for "Exer" Catheter Fixation Device (Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 06fc2ab58bff465c4d9bdb82db27963d and manufactured by Bonte Biotechnology Co., Ltd. Yilan Plant 2. The authorized representative in Taiwan is BIOTEQUE CORPORATION.
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