Amara view full face mask - PMDA ID 670277_13B1X00221000107_A_01_05
Access comprehensive regulatory information for Amara view full face mask (アマラビュー 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_13B1X00221000107_A_01_05 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 intended to be used as an interface to perform CPAP treatment or bi-level treatment on patients, for one patient at home and for multiple patients in hospitals and medical institutions. The product is used in patients prescribed CPAP treatment or bilevel therapy (body weight > 30 kg).
本品は、患者にCPAP治療またはバイレベル治療を行うためのインターフェイスとして使用することを目的とし、在宅では1人の患者に、病院・医療機関では複数の患者に使用する。本品は、CPAP治療またはバイレベル治療を処方された（体重30 kgを超える）患者に使用する。