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Fully automatic urine formed component analysis device UF-1000i - PMDA ID 480585_28B1X10014000052_A_03_01

全自動尿中有形成分分析装置 UF−1000i

Access comprehensive regulatory information for Fully automatic urine formed component analysis device UF-1000i (全自動尿中有形成分分析装置 UF−1000i) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 480585_28B1X10014000052_A_03_01 and manufactured by Manufacture and sales/Sysmex Corporation. The device information was last updated on August 17, 2020.

This page provides complete registration details including device class (A1900), classification (Urine Sediment Analysis Device / 尿沈渣分析装置), 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
A1900
480585_28B1X10014000052_A_03_01
MD
A1900
Fully automatic urine formed component analysis device UF-1000i
全自動尿中有形成分分析装置 UF−1000i
PMDA ID: 480585_28B1X10014000052_A_03_01
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Intended Use / 使用目的
English

This is a dedicated device that automatically counts urine sediment by flow cytometry. Be sure to refer to the instruction manual. 1/3Code No.461-1543-6

日本語 (Japanese)

フローサイトメトリー法により、尿沈渣を自動で計数する専用装置です。取扱説明書を必ず参照してください。1/3Code No.461-1543-6

Device Classification / 分類
Device Type
MD
Device Class
A1900
Class Name (English)
Urine Sediment Analysis Device
Class Name (日本語)
尿沈渣分析装置
Registration Information / 登録情報
PMDA ID
480585_28B1X10014000052_A_03_01
Last Update Date
August 17, 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)
Fully automatic urine formed component analysis device UF-1000i
Market Name (日本語)
全自動尿中有形成分分析装置 UF−1000i