Taiwan FDA registration 43f293beffe2081c4255b24592e2b47d
“Shawen Dane” limb orthosis (Non-Sterile)
TW: “小東”肢體裝具 (未滅菌)
Taiwan·Risk Class 1·MD·Xiaodong Enterprise Limited·Registered Oct 01, 2021 – Oct 31, 2025ExpiredRegistration details
- Analysis ID
- 43f293beffe2081c4255b24592e2b47d
- License Form
- Ministry of Health Medical Device Manufacturing Registration No. 005517
Company information
- Manufacturer
- Xiaodong Enterprise Limited
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Xiaodong Enterprise Limited
Product details
- Intended Use
- Limited to the first level recognition range of limb equipment (O.3475) of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3475 Body Equipment
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2025
About this record
Access comprehensive regulatory information for “Shawen Dane” limb orthosis (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 43f293beffe2081c4255b24592e2b47d and manufactured by Xiaodong Enterprise Limited. The authorized representative in Taiwan is Xiaodong Enterprise Limited.
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