MEDA CO., LTD.

MEDA Co., Ltd. specializes in ultrasound-based medical devices. Their portfolio includes ophthalmology tools like ultrasonic biometers and biomicroscopes, which measure eye dimensions for surgical planning, as well as bladder scanners for non-invasive fluid volume assessment. These devices rely on ultrasound technology to provide critical diagnostic or preoperative data.

MEDA Co., Ltd. is headquartered in China. While the company’s location doesn’t inherently determine regulatory classification, its devices fall under EU Class II/IIa and are listed in EUDAMED, indicating compliance with European medical device regulations. Similarly, some of their products appear in the FDA’s 510(k) registry, reflecting their market presence in the U.S.

MEDA Co., Ltd.’s devices are documented in EUDAMED, the European Union’s medical device registry, and the FDA’s 510(k) premarket notification database for the U.S. market. These listings reflect their regulatory submissions for Class II/IIa devices, which require stricter scrutiny due to their role in critical measurements (e.g., eye anatomy or bladder volume).

MEDA Co., Ltd.’s devices are classified as Class II or Class IIa under EU medical device regulations. This classification is based on their intended use—ultrasonic biometers and biomicroscopes (Class II) for high-risk procedures like eye surgery, and bladder scanners (Class IIa) for monitoring fluid volume. Higher classes require more rigorous design controls and clinical evidence to ensure safety and performance.