HOTRY (Beijing) Co., Ltd.

HOTRY (Beijing) Co., Ltd. specializes in reusable surgical instruments, specifically open-surgery dissectors and instrument trays. Dissectors are tools used to separate tissue during surgery, while instrument trays help organize and hold surgical instruments efficiently. The company’s focus is on these categories, as reflected in their example devices.

HOTRY (Beijing) Co., Ltd. is based in the United States. While the company’s location influences its regulatory obligations, it does not inherently determine whether individual devices are authorized. Instead, each device’s classification and compliance with applicable regulations—such as FDA requirements—determine its authorization status.

HOTRY’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides transparency on the devices’ identities, classifications, and regulatory status. Listing in the UDI database helps healthcare providers, regulators, and other stakeholders verify and track the devices’ compliance with FDA requirements.

HOTRY’s devices are classified as Class I medical devices. This classification is typically assigned to low-risk products that pose minimal potential harm to users. Class I devices often require less stringent regulatory oversight compared to higher-risk classes, but they still must meet basic safety and performance standards to ensure safe use in clinical settings.