Taiwan FDA registration d52c2f795fff31a8cc43ae979993839e

"Botit" manual instruments for general surgery (unsterilized)

TW: "波提特"一般手術用手動式器械(未滅菌)

Taiwan·Risk Class 1·SHINEO TECHNOLOGY CO., LTD.·Registered Feb 22, 2018 – Feb 22, 2023Expired

Registration details

Analysis ID: d52c2f795fff31a8cc43ae979993839e

Company information

Manufacturer: SHINEO TECHNOLOGY CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOTEGY CORPORATION

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Manual Instruments for General Surgery (I.4800)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4800 Hand Instruments for General Surgery
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Feb 22, 2018
Expiry Date: Feb 22, 2023

About this record

Access comprehensive regulatory information for "Botit" manual instruments for general surgery (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d52c2f795fff31a8cc43ae979993839e and manufactured by SHINEO TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is BIOTEGY CORPORATION.

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