Coastalaware Holdings Inc

Coastalaware Holdings Inc specializes in infrared patient thermometers designed for measuring skin temperature. These devices are intended for clinical use to quickly assess body temperature, particularly for detecting fever or hypothermia in healthcare settings. The focus is on non-contact, rapid temperature readings, making them suitable for environments like hospitals, clinics, or emergency care.

Coastalaware Holdings Inc is based in the United States. Its devices are primarily intended for use within the U.S. market, where they must comply with applicable medical device regulations, including those governing Class II devices. The company’s products are designed to meet the needs of healthcare providers in clinical settings.

Coastalaware Holdings Inc’s infrared skin thermometers fall under FDA Class II classification. This classification is assigned based on the device’s intended use and risk level—Class II devices generally require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The classification influences regulatory requirements, including labeling, manufacturing practices, and compliance documentation.

Yes, Coastalaware Holdings Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, reduce medical errors, and enhance transparency in the supply chain. Listing in this database is a requirement for Class II devices in the U.S., ensuring traceability and compliance with regulatory reporting standards.