Taiwan FDA registration 3d61dcba843bf3992e421b6eb3c413b0

"Asahi Kasei" white blood cell filter (for red blood cells)

TW: "旭化成" 白血球過濾器(紅血球用)

Taiwan·Risk Class 2·ASAHI KASEI TRANSFUSION TECHNOLOGY CO., LTD.·Registered Apr 16, 2021 – Apr 16, 2026Expired

Registration details

Analysis ID: 3d61dcba843bf3992e421b6eb3c413b0
Customs Code: DHA09200103303

Company information

Manufacturer: ASAHI KASEI TRANSFUSION TECHNOLOGY CO., LTD.
Manufacturer Country: China
Authorized Representative: Y.H. BIOTEK CO., LTD.

Product details

Intended Use: This product is suitable for the removal of white blood cells in 1 unit of red blood cell concentrate (prepared by 500ml whole blood).
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9100 Containers for the collection and disposal of blood and blood components
Import Information: Chinese goods;; Input;; QMS/QSD

Dates and status

Registration Date: Apr 16, 2021
Expiry Date: Apr 16, 2026

About this record

Access comprehensive regulatory information for "Asahi Kasei" white blood cell filter (for red blood cells) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3d61dcba843bf3992e421b6eb3c413b0 and manufactured by ASAHI KASEI TRANSFUSION TECHNOLOGY CO., LTD.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..

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