Infitek Co., Ltd.

Infitek Co., Ltd. specializes in laboratory equipment, including devices like general-purpose centrifuges (such as microplate and high-speed refrigerated centrifuges), automated laboratory incubators (including CO₂ incubators), and in vitro diagnostics (IVD) instruments like nucleic acid sample preparation devices and microscope slide stainers. Their portfolio also includes reusable sterilization/disinfection containers and broader lab tools like electric suction machines, refrigerators, and specialized devices such as rotary evaporators and titrators.

Infitek Co., Ltd. is based in China. While the company’s location influences its regulatory strategy—such as compliance with Chinese medical device regulations—its devices listed in the EUDAQS database (eudamed) are classified under EU regulations. This means their products, like Class A or Class I devices, must meet EU-specific requirements for safety, performance, and conformity assessment, even if they originate outside the EU.

Infitek Co., Ltd.’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This listing is important because it demonstrates compliance with EU regulatory requirements, such as device classification (Class A or Class I) and adherence to directives like MDR or IVDR. Listing in eudamed ensures transparency for healthcare providers, regulators, and authorities when assessing the legitimacy and conformity of the company’s products within the EU market.

Infitek Co., Ltd.’s devices are classified as Class A or Class I under EU regulations. This classification indicates a lower risk profile compared to higher-class devices, meaning they typically require less stringent pre-market evaluation. For example, Class I devices may only need to comply with general safety and performance requirements without mandatory third-party involvement, while Class A (a subset of Class I) may involve additional manufacturing controls. The classification ensures these devices meet basic regulatory standards for safe use in their intended applications.