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Multi-item automatic blood cell analyzer XE-2100 - PMDA ID 480585_28B1X10014000053_A_03_01

多項目自動血球分析装置 XE−2100

Access comprehensive regulatory information for Multi-item automatic blood cell analyzer XE-2100 (多項目自動血球分析装置 XE−2100) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 480585_28B1X10014000053_A_03_01 and manufactured by Manufacture and sales/Sysmex Corporation. The device information was last updated on September 04, 2020.

This page provides complete registration details including device class (A1700), classification (blood cell counter / 血球計数装置), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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PMDA Official Data
Bilingual (EN/JP)
MD
A1700
480585_28B1X10014000053_A_03_01
MD
A1700
Multi-item automatic blood cell analyzer XE-2100
多項目自動血球分析装置 XE−2100
PMDA ID: 480585_28B1X10014000053_A_03_01
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Intended Use / 使用目的
English

1. Intended use This product is a device that measures blood counts by the electric resistance method.

日本語 (Japanese)

1.使用目的本品は、電気抵抗法により血球数を計測する装置です。

Device Classification / 分類
Device Type
MD
Device Class
A1700
Class Name (English)
blood cell counter
Class Name (日本語)
血球計数装置
Registration Information / 登録情報
PMDA ID
480585_28B1X10014000053_A_03_01
Last Update Date
September 04, 2020
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/シスメックス株式会社
Product Names / 製品名
Market Name (English)
Multi-item automatic blood cell analyzer XE-2100
Market Name (日本語)
多項目自動血球分析装置 XE−2100