Taiwan FDA registration 94978b4dfef512dcbba6627d5390b2ab

"Bo Sheng" platelet concentrator

TW: “博晟” 血小板濃縮器

Taiwan·Risk Class 2·Bosheng Biomedical Co., Ltd.;; Yuren Medical Equipment Technology Co., Ltd. head factory·Registered Feb 11, 2022 – Feb 11, 2027Active

Registration details

Analysis ID: 94978b4dfef512dcbba6627d5390b2ab

Company information

Manufacturer: Bosheng Biomedical Co., Ltd.;; Yuren Medical Equipment Technology Co., Ltd. head factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: BIOGEND THERAPEUTICS CO., LTD.

Product details

Intended Use: This product is used for blood drawn from patients and prepared into an autologous platelet thick liquid (PRP) by centrifugation.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.9245 Automated hemocytoseparator
Import Information: 國產;; 委託製造;; QMS/QSD

Dates and status

Registration Date: Feb 11, 2022
Expiry Date: Feb 11, 2027

About this record

Access comprehensive regulatory information for "Bo Sheng" platelet concentrator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 94978b4dfef512dcbba6627d5390b2ab and manufactured by Bosheng Biomedical Co., Ltd.;; Yuren Medical Equipment Technology Co., Ltd. head factory. The authorized representative in Taiwan is BIOGEND THERAPEUTICS CO., LTD..

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