Omron portable electrocardiograph HCG-8060T - PMDA ID 180860_30400BZX00046000_A_01_02
Access comprehensive regulatory information for Omron portable electrocardiograph HCG-8060T (オムロン携帯型心電計HCG-8060T) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 180860_30400BZX00046000_A_01_02 and manufactured by Manufacture and sales/OMRON HEALTHCARE CO., LTD.. The device information was last updated on October 04, 2022.
This page provides complete registration details including device class (A2100), classification (ictal cardiography device / 発作時心臓活動記録装置), 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.
This product has the function of analyzing the data acquired from the ECG record and notifying the patient of the result. ECG records are carried by patients under medical supervision and used by patient manipulation during seizures. Please be sure to refer to the instruction manual.
本品は、心電図記録から取得したデータを解析し、その結果を患者に通知する機能を持ちます。心電図記録は、医師の指導を受けた患者が携行し、発作時に患者の操作によって使用されます。取扱説明書を必ずご参照下さい。