Amaraview SE full face mask - PMDA ID 670277_13B1X00221000114_A_01_04
Access comprehensive regulatory information for Amaraview SE full face mask (アマラビュー SE フルフェイスマスク) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 670277_13B1X00221000114_A_01_04 and manufactured by Philips Japan Co., Ltd.. The device information was last updated on July 20, 2022.
This page provides complete registration details including device class (A0600), classification (respirator mask / 人工呼吸器用マスク), 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.
This product is used as an interface to perform non-invasive ventilation to the patient. It is used as a ventilator accessory to provide positive pressure ventilation for the treatment of breathing disorders, respiratory dysfunction and obstructive sleep apnea, with appropriate alarms and safety devices for ventilation failure, and is used for one patient only at home and multiple patients in hospitals and medical facilities. This product is used for patients suitable for non-invasive ventilation (over 30 kg).
本品は、患者に非侵襲的換気を行うためのインターフェイスとして使用される。本品は、換気不全に対する適切なアラームや安全装置を備え、呼吸障害、呼吸機能不全、閉塞性睡眠時無呼吸の治療のために陽圧換気を提供する人工呼吸器の付属品として使用され、在宅では一人の患者のみに、病院・医療施設では複数の患者に使用される。本品は非侵襲的換気に適した患者（30kgを超える）に使用される。