Taiwan FDA registration d0bbff812f34cfafb3c25af6d9fe50c2
KEN DALL External assembled lower limb prosthesis (Non-Sterile)
TW: 肯達路 體外組裝下肢義肢(未滅菌)
Taiwan·Risk Class 1·MD·Kenda Road Enterprise Co., Ltd. Xinzhuang Factory·Registered Apr 07, 2023 – Apr 07, 2028ActiveRegistration details
- Analysis ID
- d0bbff812f34cfafb3c25af6d9fe50c2
- License Form
- Ministry of Health Medical Device Manufacturing No. 009838
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Kenda Road Enterprise Co., Ltd. Xinzhuang Factory
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment, in vitro assembly of lower limb prosthetics (O.3500) first level recognition range.
- Product Type (Level 1)
- o Physical Medical Sciences
- Product Type (Level 2)
- O3500 Lower limb prosthesis assembled in vitro
- Import Information
- Produced in Taiwan, China; GMP
Dates and status
- Registration Date
- Apr 07, 2023
- Expiry Date
- Apr 07, 2028
About this record
Access comprehensive regulatory information for KEN DALL 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 d0bbff812f34cfafb3c25af6d9fe50c2 and manufactured by Kenda Road Enterprise Co., Ltd. Xinzhuang Factory. The authorized representative in Taiwan is Kenda Road Enterprise Co., Ltd. Xinzhuang Factory.
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