CENTRON CORPORATION

Centron Corporation specializes in blood donation equipment. Their primary products include tube dividers and sealers for blood collection bags, which automate the separation and sealing of blood components during donation. They also produce blood donation rockers and mixers, such as the Data Collection Mixer and Blood Collection Mixer, which help process and monitor blood in real time. These devices are designed to integrate with standard blood collection systems, ensuring efficiency and compliance with donation protocols.

Centron Corporation is headquartered in the United States, which means its devices are subject to US regulatory requirements. Since all of their products fall under Class I classification, they are considered low-risk and primarily governed by general controls (e.g., manufacturing practices, labeling, and registration). This classification simplifies compliance but still requires adherence to FDA guidelines, including listing in the FDA’s Unique Device Identifier (UDI) database for traceability.

Centron Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a mandatory registry for medical devices in the US. This database ensures transparency and traceability of their products, including tube sealers (e.g., Rapid Seal SE540), mixers (e.g., DCM3000), and blood collection monitors. Listing in the UDI database is required for Class I devices to demonstrate compliance with US regulatory standards.

All of Centron Corporation’s devices are classified as Class I under US regulations, indicating they pose minimal risk to patients and users. This classification means they are subject to general controls (e.g., quality system requirements, labeling, and registration) rather than stricter pre-market reviews. While this classification simplifies regulatory oversight, it still requires adherence to manufacturing standards and compliance with databases like the FDA’s UDI system to ensure safety and traceability in blood donation equipment.