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Non-mydriatic fundus camera NW500 - PMDA ID 480068_304AABZX00008000_A_01_01

無散瞳眼底カメラ NW500

Access comprehensive regulatory information for Non-mydriatic fundus camera NW500 (無散瞳眼底カメラ NW500) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 480068_304AABZX00008000_A_01_01 and manufactured by Manufacture and sales/Topcon Co., Ltd.. The device information was last updated on October 06, 2022.

This page provides complete registration details including device class (A2200), classification (fundus camera / 眼底カメラ), 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
A2200
480068_304AABZX00008000_A_01_01
MD
A2200
Non-mydriatic fundus camera NW500
無散瞳眼底カメラ NW500
PMDA ID: 480068_304AABZX00008000_A_01_01
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Intended Use / 使用目的
English

The fundus is observed, photographed or recorded through the pupil without contacting the subject, and fundus image information is provided for diagnosis.

日本語 (Japanese)

被検眼に接触せずに瞳孔を通じて眼底を観察、撮影又は記録し、眼底画像情報を診断のために提供する。

Device Classification / 分類
Device Type
MD
Device Class
A2200
Class Name (English)
fundus camera
Class Name (日本語)
眼底カメラ
Registration Information / 登録情報
PMDA ID
480068_304AABZX00008000_A_01_01
Last Update Date
October 06, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/株式会社トプコン
Product Names / 製品名
Market Name (English)
Non-mydriatic fundus camera NW500
Market Name (日本語)
無散瞳眼底カメラ NW500