Taiwan FDA registration 1b4112fe11e78c8bd979b954e6ba7625
"Taiwan Tomei" External assembled lower limb prosthesis (Non-Sterile)
TW: "台灣東名" 體外組裝下肢義肢 (未滅菌)
Taiwan·Risk Class 1·MD·TAIWAN TOMEI BRACE LTD.·Registered Apr 19, 2019 – Apr 19, 2024ExpiredRegistration details
- Analysis ID
- 1b4112fe11e78c8bd979b954e6ba7625
- License Form
- Ministry of Health Medical Device Manufacturing No. 007731
Company information
- Manufacturer
- TAIWAN TOMEI BRACE LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- TAIWAN TOMEI BRACE LTD.
Product details
- Intended Use
- Limited to the first level recognition range of the in vitro assembly of lower limb prosthetics (O.3500) in the management measures for medical devices.
- Product Type (Level 1)
- o Equipment for physical medicine
- Product Type (Level 2)
- O3500 Lower limb prosthesis assembled in vitro
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Apr 19, 2019
- Expiry Date
- Apr 19, 2024
About this record
Access comprehensive regulatory information for "Taiwan Tomei" External assembled lower limb prosthesis (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 1b4112fe11e78c8bd979b954e6ba7625 and manufactured by TAIWAN TOMEI BRACE LTD.. The authorized representative in Taiwan is TAIWAN TOMEI BRACE LTD..
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