Japan PMDA registration 381005_30300BZX00166000_A_01_05

EnSite X EP System

JP: EnSite X EPシステム
Japan flagJapan·MD·A2100·Updated February 12, 2025
Device classification / 分類
Device Type
MD
Device Class
A2100
Class Name (English)
Cardiac catheter examination system
Class Name (日本語)
心臓カテーテル用検査装置
Registration information / 登録情報
PMDA ID
381005_30300BZX00166000_A_01_05
Last Update Date
February 12, 2025
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
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
About this record

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_05 and manufactured by Manufacturing and sales: Abbott Medical Japan LLC. The device information was last updated on February 12, 2025.

This page provides complete registration details including device class (A2100), classification (Cardiac catheter examination system / 心臓カテーテル用検査装置), manufacturer information (English and Japanese), 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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