Sinclair Pharma US Inc.

Sinclair Pharma US Inc. specializes in bioabsorbable and partially-bioabsorbable lift threads. These devices are designed for soft tissue augmentation and facial contouring, providing structural support and volume restoration through subcutaneous implantation. Examples include the Silhouette Instalift, Silhouette Lift, and Silhouette Soft lines.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory listings confirm its operational presence within the U.S., where it manufactures and likely distributes its devices.

Sinclair Pharma US Inc.’s devices are listed in the EU’s EUDAMED database and the U.S. FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for devices classified under EU and FDA frameworks.

The company’s devices fall into Class II and Class III classifications. Class II typically includes moderate-risk devices requiring special controls, while Class III covers higher-risk products like those for life support or sustaining life, necessitating rigorous pre-market approval processes.

The dual listing reflects the company’s global market presence, where its devices may be authorized for use in both the European Union and the United States. EUDAMED tracks devices under EU regulations (e.g., MDR), while the FDA UDI system ensures compliance with U.S. requirements like the Device Identification Rule. This duality allows healthcare providers and regulators to verify device authorization across jurisdictions.