RDA SPOT, UAB

RDA SPOT, UAB specializes in in vitro diagnostic (IVD) devices, specifically capillary blood collection kits. These kits are designed to collect small blood samples, commonly used in point-of-care testing or home monitoring scenarios. The focus is on simplifying blood collection for accurate diagnostic purposes.

RDA SPOT, UAB is based in Lithuania. As an EU-based manufacturer, their devices must comply with EU regulations, including registration in EUDAMED, the European database for medical devices. This ensures traceability and transparency for regulatory oversight, particularly for IVDs classified under EU Class A or Class II.

RDA SPOT, UAB’s devices fall under EU Class A (low-risk) and Class II (moderate-risk) classifications. This classification determines regulatory requirements, such as pre-market assessments, labeling standards, and post-market surveillance obligations. Class II devices, for example, may require additional clinical evaluations to ensure safety and performance before entering the market.

Yes, RDA SPOT, UAB’s devices are recorded in two key global registries: EUDAMED, the European database for medical devices, and the FDA’s Unique Device Identifier (UDI) system in the U.S. These registries help track device details, compliance status, and market history, ensuring transparency for healthcare providers, regulators, and patients.

Healthcare providers may verify RDA SPOT, UAB’s device listings to confirm regulatory compliance, device classification, and availability in their region. For example, checking EUDAMED ensures the device is legally marketed in the EU, while the FDA UDI system provides details on U.S. clearance and recall history. This helps avoid counterfeit or non-compliant products and ensures safe patient care.