EnSite X EP system
Japan·MD·A2100·Updated April 18, 2022- English
- This product is a cardiac catheterization device used for diagnosis in cardiac electrophysiological examination, and displays information such as cardiac potential and catheter position information.
- 日本語 (Japanese)
- 本品は、心臓電気生理学的検査において、診断に使用される心臓カテーテル検査装置であり、心臓の電位等の情報及びカテーテルの位置情報を表示する。
- Device Type
- MD
- Device Class
- A2100
- Class Name (English)
- Cardiac catheter examination device
- Class Name (日本語)
- 心臓カテーテル用検査装置
- PMDA ID
- 381005_30300BZX00166000_A_01_02
- Last Update Date
- April 18, 2022
- Official Documents
- View PDF (PMDA)
- 日本語 (Japanese)
- 製造販売／アボットメディカルジャパン合同会社
Access comprehensive regulatory information for EnSite X EP system (EnSite X EPシステム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 381005_30300BZX00166000_A_01_02 and manufactured by Manufacture and sales / Abbott Medical Japan G.K.. The device information was last updated on April 18, 2022.
This page provides complete registration details including device class (A2100), classification (Cardiac catheter examination device / 心臓カテーテル用検査装置), 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.