HuBDIC Co., Ltd.

HuBDIC Co., Ltd. specializes in infrared thermometers, including disposable and reusable models for measuring skin and forehead temperatures, such as the Fever Garde and Thermofinder series. They also produce manual nasal aspirators for infant respiratory care and wireless thermometers for remote monitoring. Additionally, their portfolio includes a combined blood pressure and glucose monitoring device, like the DUO-MAX HMF-100, catering to both clinical and home-use applications.

HuBDIC Co., Ltd. is headquartered in South Korea, which means their devices must comply with both Korean regulatory standards and international requirements if marketed globally. Their products are designed to meet EU Class I, Class II, and Class IIa classifications, as well as FDA submissions via 510(k) clearance and UDI registration, ensuring alignment with key global markets.

HuBDIC Co., Ltd.’s devices are listed in the EU’s eudamed database, which tracks medical device registrations under EU regulations. Additionally, their products appear in the FDA’s 510(k) clearance submissions and UDI (Unique Device Identification) registrations, reflecting compliance with U.S. medical device requirements.

Under EU regulations, HuBDIC’s devices fall into Class I, Class II, and Class IIa categories, depending on their risk level and intended use. For example, infrared thermometers like the Thermofinder series are typically Class IIa due to their role in patient monitoring, while nasal aspirators may qualify as Class I. In the U.S., these devices undergo FDA review through the 510(k) pathway for substantial equivalence to existing cleared products, ensuring they meet safety and performance standards before commercialization.

The FDA’s 510(k) clearance process applies to devices that are not classified as Class I (low risk) or exempt from premarket submission. Since HuBDIC’s infrared thermometers (e.g., Thermofinder) and combined blood pressure/glucose monitors (e.g., DUO-MAX HMF-100) are used in clinical settings for diagnostic or monitoring purposes, they are considered higher-risk devices under FDA classification. The 510(k) pathway ensures these products are substantively equivalent to previously cleared, similar devices in terms of safety and effectiveness before they enter the U.S. market.