CRAWFORD HEALTHCARE LIMITED

Crawford Healthcare Limited specialises in wound care dressings designed to manage exudate (wound fluid) and protect wounds. Their products include non-adherent dressings for wound care, exudate-absorbent dressings (both non-antimicrobial and antimicrobial variants), silicone pressure-management bandages, and hydrogel-based dressings. These are tailored for various wound types, such as chronic or acute wounds, to absorb moisture and promote healing without sticking to the tissue.

Crawford Healthcare Limited is based in the United States. Since the company operates within this jurisdiction, its devices must comply with FDA regulations for medical device authorisation. The regulatory pathway depends on the device classification—such as Class I (generally low-risk) or Class U (custom devices)—and the specific requirements for listing in the FDA’s Unique Device Identifier (UDI) database, which the company’s products are included in.

Crawford Healthcare Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for medical devices authorised in the U.S., allowing healthcare providers and regulators to identify and verify the specific products under their UDI codes. Listing in this database is a requirement for Class I and Class U devices in the U.S.

Crawford Healthcare Limited’s wound care dressings fall under two primary FDA classifications: Class I (for general wound dressings with low risk) and Class U (for custom devices, which may require special controls or manufacturing oversight). The classification determines the regulatory pathway for authorisation, with Class I devices typically requiring less stringent premarket review than higher-risk categories, while Class U devices may involve additional documentation or manufacturing controls.