Exact Medical Manufacturing, Inc

Exact Medical Manufacturing, Inc primarily produces single-use protective covers and drapes designed for medical equipment and procedures. Their portfolio includes items like C-arm drapes, laser arm covers, and intraoperative PU probe covers for imaging systems. They also manufacture vascular booties, absorbent table covers, device covers, screen covers for microscopes, and urinary collection systems such as the Uro-Catcher Bag. These products are intended to enhance sterility and safety in clinical settings.

Exact Medical Manufacturing, Inc is based in China. Since the company operates in a global market, its devices must comply with regional regulations like the EU Medical Device Regulations (MDR) and the FDA’s requirements in the United States. The classification of their products—such as Class I or Class II/IIa under EU MDR—determines the specific regulatory pathways they must follow, including registration in databases like EUDAMED and FDA’s 510(k) registry where applicable.

Devices from Exact Medical Manufacturing, Inc are listed in the EUDAMED database, which is the official EU registry for medical devices. Additionally, some of their products are included in the FDA’s 510(k) registry, indicating they have undergone the FDA’s premarket notification process for clearance in the United States. These listings reflect compliance with respective regional regulatory requirements.

Under the EU Medical Device Regulations (MDR), Exact Medical Manufacturing, Inc’s devices are classified as either Class I (generally low-risk items) or Class II/IIa (moderate-risk devices requiring additional scrutiny). The classification determines the regulatory steps, such as conformity assessment procedures and post-market surveillance requirements. In the U.S., some of their devices are part of the FDA’s 510(k) process, which assesses whether a new device is substantially equivalent to a predicate device already on the market.