Taiwan FDA registration 8261d9be5d2dbc093410002e1c559264

Beckman Coulter PK7400 Automated Microplate System

TW: 貝克曼庫爾特輸血前全自動血液分析儀

Taiwan·Risk Class 2·MD·BECKMAN COULTER MISHIMA K.K.·Registered May 28, 2019 – May 28, 2024Expired

Registration details

Analysis ID: 8261d9be5d2dbc093410002e1c559264
License Form: Ministry of Health Medical Device Import No. 032440
Customs Code: DHA05603244009

Company information

Manufacturer: BECKMAN COULTER MISHIMA K.K.
Manufacturer Country: Japan
Authorized Representative: BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: This product is a fully automated batch inspection system with Beckman Coulter microdiscs using agglutination technology. This product is used for blood donor ABO blood grouping, Rh typing, including weak D detection, red blood cell antigen screening and syphilis qualitative screening.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B9175 Automated Blood Sorting and Antibody Testing System
Import Information: Imported from abroad

Dates and status

Registration Date: May 28, 2019
Expiry Date: May 28, 2024

About this record

Access comprehensive regulatory information for Beckman Coulter PK7400 Automated Microplate System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8261d9be5d2dbc093410002e1c559264 and manufactured by BECKMAN COULTER MISHIMA K.K.. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

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