Tody Laboratories Int. SRL

Tody Laboratories Int. SRL specializes in rapid diagnostic test cassettes and urine strips readers. Their cassettes detect infectious diseases like adenovirus and rotavirus, as well as tumor markers such as CEA and AFP. The urine strips readers are designed for laboratory use to analyze urine samples. These devices are intended for point-of-care or clinical settings, providing rapid qualitative results.

Tody Laboratories Int. SRL is based in Romania. The company’s location is relevant for understanding its regulatory scope and compliance with local and EU medical device standards.

Tody Laboratories Int. SRL’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations, including the Medical Device Regulation (MDR).

Tody Laboratories Int. SRL’s devices are classified as Class A under the EU Medical Device Regulation (MDR). This classification applies to low-risk in vitro diagnostic (IVD) devices, such as rapid test cassettes and urine strips readers, which are deemed to pose minimal risk to patients when used as intended.

Tody Laboratories Int. SRL’s rapid test cassettes are designed for use with whole blood, serum, plasma, or fecal samples, depending on the specific assay. For example, TSH and tumor marker tests (like CEA and AFP) use blood-based samples, while adenovirus and rotavirus tests are intended for fecal analysis. This versatility allows for flexible use in clinical or point-of-care settings.