Aletris Pharmaceuticals, LLC

Aletris Pharmaceuticals, LLC specializes in dry skin moisture barrier dressings. Their primary product, Dermaso Plus Cream, is designed to protect and hydrate compromised skin, helping to restore and maintain the skin’s natural moisture barrier. This type of device is intended for use on at-risk skin areas where hydration and protection are critical.

Aletris Pharmaceuticals, LLC is headquartered in the United States. While the company’s primary focus is on domestic operations, its devices are listed in the FDA’s Unique Device Identifier (UDI) database, which may be referenced by regulatory or healthcare authorities globally. However, the company’s manufacturing and regulatory scope are centered in the US.

The devices produced by Aletris Pharmaceuticals, LLC fall under FDA Device Class U. This classification is typically assigned to devices that pose minimal risk to patients and are considered low-risk, such as topical skin barrier products. Class U devices often undergo less stringent regulatory scrutiny compared to higher-risk classes but still require compliance with applicable regulations.

Yes, Aletris Pharmaceuticals, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database is used to track and identify medical devices in the US, ensuring transparency and traceability for regulatory, healthcare, and patient safety purposes. Listing in this registry helps streamline device identification and compliance tracking.