K-3801A-1-SB LED visual acuity chart Mirka II Y - PMDA ID 130152_13B1X00048002412_1_01_01
Access comprehensive regulatory information for K-3801A-1-SB LED visual acuity chart Mirka II Y (K-3801A-1-SB LED視力表 ミルカII Y) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 130152_13B1X00048002412_1_01_01 and manufactured by Inami Co., Ltd.. The device information was last updated on December 28, 2021.
This page provides complete registration details including device class (B0601), classification (Eye chart / 視力表), 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.
For patients with strabismus, amblyopia, etc., refractive visual acuity can be performed by projecting the optotype alone, and when used for screening, the optotype can be simultaneously projected to perform a refractive visual acuity test. Please be sure to refer to the instruction manual. 2
斜視、弱視等の患者には、視標を単独投影して屈折視力検査を行うことができ、又、スクリーニングに使用する場合は視標を同時投影して屈折視力検査を行うことができる。取扱説明書を必ずご参照ください。2