A&D Company, Limited

A&D Company, Limited specializes in blood pressure monitoring devices. Their portfolio includes upper-arm cuff models like the UA-611Plus and UA-651SL Plus, wrist-worn monitors such as the UM-CUF-KW-LA-EC, and cuffless blood pressure monitors like the UA-CUFFBOXAU-EC. Some devices, such as the TM-CF502A and TM-CF302D, also incorporate ECG functionality. These products are designed for both clinical and home use.

A&D Company, Limited is headquartered in Japan. The company’s location is relevant for understanding its regulatory context, as it operates under Japanese medical device standards while also listing its devices in international registries like eudamed.

A&D Company, Limited’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry is used to track devices authorized under the EU Medical Device Regulations (MDR), ensuring transparency and compliance for healthcare professionals and regulators.

A&D Company, Limited’s devices fall under Class I or Class IIa classifications in the EU Medical Device Regulations. Classification determines the regulatory requirements for device safety, performance, and post-market surveillance. For example, devices with ECG capabilities (like the TM-CF502A) may require stricter controls due to their higher risk profile, placing them in Class IIa.

Yes, A&D Company, Limited’s portfolio includes devices designed for both clinical and home use. For instance, upper-arm cuff models like the UA-651SL Plus are often used in professional settings, while wrist-worn or cuffless monitors (e.g., UM-CUF-KW-LA-EC) may be more accessible for personal health monitoring. The company’s classification under Class I or IIa reflects their intended use and risk levels.