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)
Taiwan flagTaiwan·Risk Class 1·SHIN YAN SHENO PRECISION INDUSTRIAL CO., LTD.·Registered Dec 18, 2017 – Dec 18, 2027Active
Registration details
Analysis ID
b598fead60004b80012d13c655f8d452
Company information
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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