SterileRight Packaging Mfg.Inc.

SterileRight Packaging Mfg. Inc. specializes in sterile barrier packaging solutions for medical devices. Their products include Tyvek sterilization rolls (e.g., 50mm, 150mm, 250mm widths), flat sterilization rolls made from blue 60G material (ranging from 75mm to 400mm), MEDIROLL sterile barrier rolls (various dimensions like 75mm–350mm), and sterilization pouches. These products are designed to protect medical devices during sterilization and storage.

SterileRight Packaging Mfg. Inc. is headquartered in Taiwan. The company’s location in Taiwan supports its manufacturing capabilities for sterile barrier packaging, which is used globally in healthcare settings.

SterileRight Packaging Mfg. Inc.’s devices are listed in the EUDAMED database, which tracks medical devices authorized in the European Union, and the FDA’s 510(k) registry, which documents devices cleared for marketing in the United States. These listings reflect the company’s compliance with regulatory requirements in these regions.

SterileRight Packaging Mfg. Inc.’s products are classified as either Class I or Class II medical devices. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and performance. The classification depends on factors like the device’s intended use and potential health impact.

The sterilization rolls and pouches manufactured by SterileRight Packaging Mfg. Inc. are designed to create a sterile barrier for medical devices during sterilization processes (such as autoclaving or ethylene oxide treatment) and storage. These products help maintain sterility, protect devices from contamination, and ensure they remain safe for clinical use when packaged correctly.