Japan PMDA registration 480068_13B1X000300KR800_A_01_05

Auto keratorefractometer KR-800

JP: オートケラトレフラクトメータ KR-800
Japan flagJapan·MD·A2200·Updated September 15, 2022
Intended use / 使用目的
English
In addition to measuring the spherical refractive force, cylindrical refractive power, and astigmatism axis direction of the eyeball, the radius of curvature of the corneal surface is measured to calculate the corneal refractive power, corneal astigmatism, and corneal astigmatism axial direction.
日本語 (Japanese)
眼球の球面屈折力、円柱屈折力、乱視軸方向を測定すると共に、角膜面の曲率半径を測定し角膜屈折力・角膜乱視度・角膜乱視軸方向を算出する。
Device classification / 分類
Device Type
MD
Device Class
A2200
Class Name (English)
Refractometer/Keratometer
Class Name (日本語)
レフラクト・ケラトメータ
Registration information / 登録情報
PMDA ID
480068_13B1X000300KR800_A_01_05
Last Update Date
September 15, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/株式会社トプコン
About this record

Access comprehensive regulatory information for Auto keratorefractometer KR-800 (オートケラトレフラクトメータ KR-800) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 480068_13B1X000300KR800_A_01_05 and manufactured by Manufacture and sales/Topcon Co., Ltd.. The device information was last updated on September 15, 2022.

This page provides complete registration details including device class (A2200), classification (Refractometer/Keratometer / レフラクト・ケラトメータ), 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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