Prime Color Vision Co., Ltd.

Prime Color Vision Co., Ltd. specializes in devices for color vision assessment. Their primary product, the Pro Trend Color, is designed to evaluate color perception, which can be useful in clinical or diagnostic settings to identify potential deficiencies in color vision.

Prime Color Vision Co., Ltd. is headquartered in South Korea. The company’s location is relevant for understanding regulatory compliance and manufacturing standards, though it does not directly impact the classification or authorization status of individual devices.

The Pro Trend Color, Prime Color Vision Co., Ltd.’s example device, falls under EU Device Class IIa. This classification is determined by factors like the device’s intended use and potential risks, with Class IIa representing moderate-risk medical devices requiring conformity assessment procedures before market placement.

Yes, Prime Color Vision Co., Ltd.’s devices are registered in the eudamed database, which is the official EU portal for medical device information. Listing in eudamed is a requirement for manufacturers placing devices on the EU market, ensuring transparency and traceability of authorized products.