Japan PMDA registration 530225_23100BZX00054000_A_01_02

Defibrillator EMS-1052 Cardiolife EMS

JP: デフィブリレータ EMS-1052 カルジオライフEMS
Japan flagJapan·MD·A1200·Updated April 18, 2022
Intended use / 使用目的
English
1. Intended UseThis device is a defibrillator that removes ventricular fibrillation or ventricular tachycardia by energizing a large current to the heart for a short period of time. Temporary percutaneous pacing for bradycardia, monitoring of the ECG on the screen are also possible. It is mainly used in ambulances and outdoors.
日本語 (Japanese)
1. 使用目的本装置は、心臓に大電流を短時間通電させることにより、心室細動または心室性頻拍を除去する除細動器です。徐脈に対する一時的な経皮ペーシング、画面上での心電図のモニタリングも可能です。主に救急車内、屋外において使用されます。
Device classification / 分類
Device Type
MD
Device Class
A1200
Class Name (English)
Temporary use of the peshing function to pay the actuator
Class Name (日本語)
一時的使用ペーシング機能付除細動器
Registration information / 登録情報
PMDA ID
530225_23100BZX00054000_A_01_02
Last Update Date
April 18, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/日本光電工業株式会社
About this record

Access comprehensive regulatory information for Defibrillator EMS-1052 Cardiolife EMS (デフィブリレータ EMS-1052 カルジオライフEMS) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 530225_23100BZX00054000_A_01_02 and manufactured by Nihon Kohden Kogyo Co., Ltd.. The device information was last updated on April 18, 2022.

This page provides complete registration details including device class (A1200), classification (Temporary use of the peshing function to pay the actuator / 一時的使用ペーシング機能付除細動器), 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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