Taiwan FDA registration e8d238911f5e376dfdcf85b8415acae2
"Kaigu" in vitro assembly of lower limb prosthesis (unsterilized)
TW: "開谷" 體外組裝下肢義肢 (未滅菌)
Taiwan·Risk Class 1·YUAN BOR YIH ENTERPRISE CO., LTD.·Registered Oct 01, 2015 – Oct 01, 2025ExpiredRegistration details
- Analysis ID
- e8d238911f5e376dfdcf85b8415acae2
Company information
- Manufacturer
- YUAN BOR YIH ENTERPRISE CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Kaigu Limited
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)
- O.3500 shades
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- Oct 01, 2015
- Expiry Date
- Oct 01, 2025
About this record
Access comprehensive regulatory information for "Kaigu" in vitro assembly of lower limb prosthesis (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e8d238911f5e376dfdcf85b8415acae2 and manufactured by YUAN BOR YIH ENTERPRISE CO., LTD.. The authorized representative in Taiwan is Kaigu Limited.
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