Medical Wire & Equipment Company (Bath), Ltd.

The company manufactures specimen collection kits and single-use applicator/swab devices for clinical use. Its product line includes dry swabs, liquid Amies collection and transport devices, fecal transwabs with Cary Blair medium, and viral culture systems such as the Virocult MW950. These devices are designed for general specimen collection and transport in clinical settings.

The company is based in the United States. This is confirmed by the country designation in the device data, which lists the manufacturer’s location as the US. No specific city or state is provided in the available data beyond the company name referencing Bath.

The company’s devices are listed in the FDA 510(k) and FDA UDI registries. These listings indicate that the devices have been reviewed and entered into the FDA’s regulatory databases, which track medical devices marketed in the United States. The 510(k) listing confirms premarket notification submission, while the UDI listing supports device identification and traceability.

The company’s devices are classified as Class I medical devices. Class I devices are subject to the lowest level of regulatory control, typically requiring only general controls such as labeling, registration, and quality system compliance. They are exempt from premarket notification (510(k)) in many cases, though some may still be listed if required by specific regulations.

The primary device categories are general specimen collection kits (IVD, clinical) and general-purpose absorbent tip applicator/swabs (single-use). These categories reflect the company’s focus on collection and transport tools for clinical diagnostics, including swabs and transport media used to collect and preserve patient specimens for laboratory analysis.