Basera VS-2000 series - PMDA ID 670053_226ADBZX00226000_A_05_01
Access comprehensive regulatory information for Basera VS-2000 series (バセラ VS-2000シリーズ) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 670053_226ADBZX00226000_A_05_01 and manufactured by Manufacture and sales/Fukuda Denshi Co., Ltd.. The device information was last updated on October 03, 2022.
This page provides complete registration details including device class (A1800), classification (blood pressure plethysmograph / 血圧脈波検査装置), 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.
Intended use 1.Blood pressure pulse wave testThis device measures non-invasive blood pressure in the extremities and simultaneously collects a phonocardiogram, a pulse wave chart of the extremities, etc., to examine the extensibility of the patient's arteries and the degree of blood flow disturbance in the blood vessels of the lower extremities. 2. Electrocardiography This device performs at least 12 lead electrocardiograms including limb guidance and chest guidance, records electrocardiograms and analysis results at clinics, hospitals, etc., and is intended to be used for general electrocardiography such as screening for heart diseases.
使用目的1.血圧脈波検査本装置は、四肢の非観血血圧を計測し、心音図、四肢の脈波図等を同時に採取することにより、患者の動脈の伸展性および下肢血管の血流障害の程度を検査することを目的とします。2.心電図検査本装置は、四肢誘導および胸部誘導を含む最低 12誘導の心電図検査を行い、診療所、病院等で心電図および解析結果等を記録して、心臓疾患のスクリーニング等、一般の心電図検査等に使用することを目的とします。