ACRE PHARMA LIMITED

ACRE Pharma Limited specializes in two primary categories of medical devices: synovial fluid supplementation mediums and dermal tissue reconstructive materials. Their synovial fluid products, such as Synvisc One, Orthovisc, and Monovisc, are hyaluronic acid-based injectables designed to lubricate and cushion joints. Meanwhile, their dermal tissue reconstructive materials, like Restylane and Restylane Lyft, are animal-derived substances used for soft tissue augmentation, often in cosmetic or reconstructive procedures.

ACRE Pharma Limited is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since the company operates within the U.S., its products must comply with FDA regulations, including classification, registration, and listing requirements. This ensures that the devices meet the necessary standards for safety, efficacy, and quality before they are authorized for use.

ACRE Pharma Limited’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices throughout their distribution and helps ensure traceability, reducing errors in ordering, labeling, and tracking. Since all listed devices fall under FDA Class III regulation, they are required to be included in this database as part of compliance.

ACRE Pharma Limited’s devices are classified as FDA Class III. This classification applies to products that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury if they fail. Due to their critical role in joint lubrication and soft tissue augmentation, these devices undergo rigorous premarket approval (PMA) or other stringent review processes to ensure their safety and effectiveness before authorization.