Taiwan FDA registration 8e15a348ad1b0172ee354d0382a2120c

"Shimei" medical suture needle (sterilized/unsterilized)

TW: “仕美”醫療用縫合針 (滅菌/未滅菌)

Taiwan·Risk Class 1·SM ENG. Co., Ltd.·Registered Feb 09, 2022 – Feb 09, 2027Active

Registration details

Analysis ID: 8e15a348ad1b0172ee354d0382a2120c
Customs Code: DHA09402274009

Company information

Manufacturer: SM ENG. Co., Ltd.
Manufacturer Country: Korea, Republic of
Authorized Representative: MIN SHIN INSTRUMENTS CO., LTD.

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: Input;; QMS/QSD

Dates and status

Registration Date: Feb 09, 2022
Expiry Date: Feb 09, 2027

About this record

Access comprehensive regulatory information for "Shimei" medical suture needle (sterilized/unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8e15a348ad1b0172ee354d0382a2120c and manufactured by SM ENG. Co., Ltd.. The authorized representative in Taiwan is MIN SHIN INSTRUMENTS CO., LTD..

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