Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung

Labotect produces two primary categories of medical devices: single-use assisted reproduction needles and transfer catheter sets, which are used in fertility treatments, and aerobic laboratory incubators like the CO₂ Inkubator Labo C-Top. These incubators are designed for maintaining controlled environments—such as precise temperature and gas conditions—for biological samples, particularly in cell culture applications.

Labotect is based in Germany but has a presence in the US, where it operates under applicable regulatory requirements for medical devices. While the company itself is not based in the US, its products are distributed and used there, including those listed in the FDA’s Unique Device Identifier (UDI) database.

Labotect’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the US market, including those classified under FDA’s Class I and Class II categories, such as their assisted reproduction devices and laboratory incubators.

Labotect’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The specific classification depends on the device’s intended use and potential risks, such as the single-use needles and incubators produced by the company.