WINIADIMCHAE Co., Ltd.

WINIADIMCHAE Co., Ltd. specializes in blood refrigerator/freezer devices, specifically ultra-low temperature freezers. These are designed to store blood at extremely cold temperatures to preserve its viability for long-term use in medical applications. The focus is on ensuring safe and effective preservation of biological samples.

WINIADIMCHAE Co., Ltd. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they undergo a premarket notification (510(k)) process or other applicable pathways to demonstrate substantial equivalence to a legally marketed predicate device before entering the market.

WINIADIMCHAE Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the specific devices in use. Listing in the UDI system is mandatory for Class II devices in the U.S.

WINIADIMCHAE Co., Ltd.’s ultra-low temperature freezers are classified as Class II devices by the FDA. This classification indicates moderate risk, requiring manufacturers to submit a 510(k) premarket notification (or another pathway like De Novo) to demonstrate the device’s safety and effectiveness compared to an existing predicate. Class II devices undergo additional scrutiny to ensure they meet performance standards without posing unreasonable risks.