Vietnam MOH registration 240000723/PCBB-HN

IVD Material Cluster for the Assessment of Hematological Parameters

VN: Cụm IVD vật liệu kiểm soát xét nghiệm các thông số huyết học

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·AMEDA Labordiagnostik GmbH·Registered Apr 05, 2024

Registration details

Analysis ID: 240000723/PCBB-HN
Submission ID: 000.00.19.H26-240329-0006
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: AMEDA Labordiagnostik GmbH
Manufacturer Country: Theo theo phụ lục
Product Owner: AMEDA Labordiagnostik GmbH
Authorized Representative: CÔNG TY TNHH PHÁT TRIỂN VÀ CHUYỂN GIAO CÔNG NGHỆ THỊNH PHÁT

Technical details

Intended Use: It is a hematology control material used to determine the accuracy, precision, and linearity of hematology analyzers, both semi-automatic and fully automatic, based on the impedance principle.

Dates and status

Registration Date: Apr 05, 2024

About this record

Access comprehensive regulatory information for IVD Material Cluster for the Assessment of Hematological Parameters in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000723/PCBB-HN and manufactured by AMEDA Labordiagnostik GmbH. The authorized representative in Vietnam is CÔNG TY TNHH PHÁT TRIỂN VÀ CHUYỂN GIAO CÔNG NGHỆ THỊNH PHÁT.

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