Taiwan FDA registration 94ac50638c37dfa635c1c7b75e92797b
“YASCO” External assembled lower limb prosthesis (Non-Sterile)
TW: “昭惠” 體外組裝下肢義肢 (未滅菌)
Taiwan·Risk Class 1·MD·Zhaohui Industrial Co., Ltd. Chiayi Factory·Registered Feb 24, 2021 – Feb 24, 2026ExpiredRegistration details
- Analysis ID
- 94ac50638c37dfa635c1c7b75e92797b
- License Form
- Ministry of Health Medical Device Manufacturing No. 008905
Company information
- Manufacturer
- Zhaohui Industrial Co., Ltd. Chiayi Factory
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Zhaohui Industrial Co., Ltd. Chiayi Factory
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
- Feb 24, 2021
- Expiry Date
- Feb 24, 2026
About this record
Access comprehensive regulatory information for “YASCO” 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 94ac50638c37dfa635c1c7b75e92797b and manufactured by Zhaohui Industrial Co., Ltd. Chiayi Factory. The authorized representative in Taiwan is Zhaohui Industrial Co., Ltd. Chiayi Factory.
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