Taiwan FDA registration 883edb64a8decf066c25b599cc2c6107

Pura plas Platelet Concentrate Separator

TW: 聖美血小板濃縮液分離管

Taiwan·Risk Class 2·MD·AGREE HEALTH CARE TECHNOLOGY, LTD.;;Amedifact Co., Ltd.·Registered Feb 07, 2023 – Apr 09, 2026Expired

Registration details

Analysis ID: 883edb64a8decf066c25b599cc2c6107
License Form: Ministry of Health Medical Device Manufacturing No. 007585

Company information

Manufacturer: AGREE HEALTH CARE TECHNOLOGY, LTD.;;Amedifact Co., Ltd.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: AGREE HEALTH CARE TECHNOLOGY, LTD.

Product details

Intended Use: This product prepares platelet-rich plasma (PRP) by centrifugation by drawing a small amount of peripheral blood from the patient.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B9245 Automatic Hematology Cell Separator
Import Information: Produced in Taiwan, China; Contract manufacturing;; GMP

Dates and status

Registration Date: Feb 07, 2023
Expiry Date: Apr 09, 2026

About this record

Access comprehensive regulatory information for Pura plas Platelet Concentrate Separator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 883edb64a8decf066c25b599cc2c6107 and manufactured by AGREE HEALTH CARE TECHNOLOGY, LTD.;;Amedifact Co., Ltd.. The authorized representative in Taiwan is AGREE HEALTH CARE TECHNOLOGY, LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.