FAMIDOC USA, INC.

FAMIDOC USA, INC. produces a range of medical devices primarily focused on temperature measurement and pain management. Their portfolio includes intermittent electronic patient thermometers, infrared thermometers for skin and ear use, and transcutaneous electrical stimulation systems for pain relief and physical therapy. They also manufacture single-use electrodes and leads for these systems, as well as manual lice combs.

FAMIDOC USA, INC. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under FDA’s Class I and Class II categories, indicating varying levels of regulatory oversight depending on the device’s risk profile. Being U.S.-based also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.

FAMIDOC USA, INC.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a unique identifier for tracking, compliance, and transparency in the medical device supply chain. The UDI system helps healthcare providers, regulators, and manufacturers maintain accurate records of device distribution and usage.

FAMIDOC USA, INC.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls like good manufacturing practices, while Class II devices involve moderate risk and may require additional performance standards or special controls. The classification depends on the device’s intended use and potential harm, with thermometers and manual lice combs typically falling under Class I, while more complex systems like transcutaneous electrical stimulation devices may be Class II.