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tetragraph - PMDA ID 670053_30100BZX00077000_A_04_01

テトラグラフ

Access comprehensive regulatory information for tetragraph (テトラグラフ) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 670053_30100BZX00077000_A_04_01 and manufactured by Manufacture and sales/Fukuda Denshi Co., Ltd.. The device information was last updated on August 19, 2022.

This page provides complete registration details including device class (A2400), classification (Neurolocating stimulator / 神経探知刺激装置), 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.

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PMDA Official Data
Bilingual (EN/JP)
MD
A2400
670053_30100BZX00077000_A_04_01
MD
A2400
tetragraph
テトラグラフ
PMDA ID: 670053_30100BZX00077000_A_04_01
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Intended Use / 使用目的
English

Intended UseThis device is used in operating rooms, postoperative recovery rooms, ICUs, etc. in hospitals to determine the degree of muscle relaxation and determine the dose of muscle relaxants by applying electrical stimulation to the peripheral nerves of patients and detecting electromyography at that time.

日本語 (Japanese)

使用目的本装置は、病院内の手術室、術後の回復室、ICU などにおいて、患者の末梢神経に電気的な刺激を与えて、その時の筋電図を検出することで、筋弛緩の程度を把握して筋弛緩剤投与量の決定を支援するために用います。

Device Classification / 分類
Device Type
MD
Device Class
A2400
Class Name (English)
Neurolocating stimulator
Class Name (日本語)
神経探知刺激装置
Registration Information / 登録情報
PMDA ID
670053_30100BZX00077000_A_04_01
Last Update Date
August 19, 2022
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/フクダ電子株式会社
Product Names / 製品名
Market Name (English)
tetragraph
Market Name (日本語)
テトラグラフ