Taiwan FDA registration b598fead60004b80012d13c655f8d452
"Koyan" manual instruments for general surgery (sterilization)
TW: “科妍”一般手術用手動器械(滅菌)
Registration details
- Analysis ID
- b598fead60004b80012d13c655f8d452
Company information
- Manufacturer
- SHIN YAN SHENO PRECISION INDUSTRIAL CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- SCIVISION BIOTECH INC.
Product details
- Intended Use
- Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
- Product Type (Level 1)
- I General, Plastic Surgery and Dermatology
- Product Type (Level 2)
- I.4800 Hand Instruments for General Surgery
- Import Information
- QMS/QSD;; 國產;; 委託製造
Dates and status
- Registration Date
- Dec 18, 2017
- Expiry Date
- Dec 18, 2027
About this record
Access comprehensive regulatory information for "Koyan" manual instruments for general surgery (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b598fead60004b80012d13c655f8d452 and manufactured by SHIN YAN SHENO PRECISION INDUSTRIAL CO., LTD.. The authorized representative in Taiwan is SCIVISION BIOTECH INC..
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