Taiwan FDA registration af962c5b15aa3f393cbf40a7f127648d

"Amtec" Erfly Endoscope Alkaline Cleaner (Unsterilized)

TW: "阿姆特克" 埃兒飛內視鏡鹼性清潔劑 (未滅菌)

Taiwan·Risk Class 1·THAI AMTEC CO., LTD.;; AMTEC CO., LTD.·Registered Jun 07, 2023 – Jun 07, 2028Active

Registration details

Analysis ID: af962c5b15aa3f393cbf40a7f127648d
Customs Code: DHA09402314500

Company information

Manufacturer: THAI AMTEC CO., LTD.;; AMTEC CO., LTD.
Manufacturer Country: Thailand;;Japan
Authorized Representative: FUJIFILM HEALTHCARE TAIWAN CO., LTD.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Classification and Grading of Medical Devices "Disinfectants for General Medical Devices (J.6890)".
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.6890 Disinfectants for general medical equipment
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jun 07, 2023
Expiry Date: Jun 07, 2028

About this record

Access comprehensive regulatory information for "Amtec" Erfly Endoscope Alkaline Cleaner (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number af962c5b15aa3f393cbf40a7f127648d and manufactured by THAI AMTEC CO., LTD.;; AMTEC CO., LTD.. The authorized representative in Taiwan is FUJIFILM HEALTHCARE TAIWAN CO., LTD..

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