Ohira Co., Ltd.

Ohira Co., Ltd. specializes in ophthalmic diagnostic devices. Their portfolio includes slit lamps, such as the SL-203, SL-102, and LED Slit Lamp XL-1, which are used to examine the front part of the eye. They also produce applanation tonometers, like the SL-TM model, which measure intraocular pressure. These devices are designed for clinical use in eye care settings.

Ohira Co., Ltd. is headquartered in Japan. The company’s location is relevant for understanding its regulatory context, as it operates within Japan’s medical device landscape while also ensuring compliance with international standards, such as EUDAMED listing for its Class I devices.

Ohira Co., Ltd.’s devices are listed in the EUDAMED database. This registry is used to track medical devices that have been authorized for placement on the European market, ensuring transparency and traceability for Class I devices like those manufactured by Ohira.

Ohira Co., Ltd.’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk devices, such as ophthalmic diagnostic tools like slit lamps and tonometers, which typically require less stringent regulatory oversight compared to higher-risk categories.