Taiwan FDA registration 91f9781108bb6e2936e6f8ad7e69e4fc
"ONP" External assembled lower limb prosthesis (Non-Sterile)
TW: "歐恩比" 體外組裝下肢義肢 (未滅菌)
Taiwan·Risk Class 1·MD·TAIWAN ONP COMPANY·Registered Sep 18, 2018 – Sep 18, 2023ExpiredRegistration details
- Analysis ID
- 91f9781108bb6e2936e6f8ad7e69e4fc
- License Form
- Ministry of Health Medical Device Manufacturing No. 007434
Company information
- Manufacturer
- TAIWAN ONP COMPANY
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- TAIWAN ONP COMPANY
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
- Sep 18, 2018
- Expiry Date
- Sep 18, 2023
About this record
Access comprehensive regulatory information for "ONP" 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 91f9781108bb6e2936e6f8ad7e69e4fc and manufactured by TAIWAN ONP COMPANY. The authorized representative in Taiwan is TAIWAN ONP COMPANY.
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