ROBERT RIELE GmbH & Co KG

Robert Riele GmbH & Co KG specializes in photometers, such as the 4040 V5+, 4040+, 680, 4040, 505, and 5010 V5+. These devices are primarily used in laboratory settings for tasks like measuring light absorption or emission, which is critical in biochemical assays, clinical diagnostics, or scientific research. The focus on photometry aligns with applications requiring precise optical analysis.

The company is headquartered in Germany, which means its photometers are subject to European Union medical device regulations. Since these devices fall under the Medical Device Regulation (MDR), they must comply with EU standards for safety, performance, and traceability. The German location also ensures alignment with EUDAMED listing requirements, a central registry for medical devices in the EU.

Yes, the company’s photometers are listed in the EUDAMED database, which is the official European Union registry for medical devices. This listing confirms their registration under the MDR, allowing them to be legally placed on the market within the EU. EUDAMED acts as a transparent resource for stakeholders to verify device details, including manufacturer information and regulatory status.

All of Robert Riele GmbH & Co KG’s photometers are classified as Class A medical devices under the EU’s Medical Device Regulation (MDR). This classification applies to devices posing minimal risk, such as those used for general laboratory measurements like light absorption or emission. Class A devices typically undergo less stringent conformity assessment than higher-risk classes but still require compliance with essential safety and performance requirements.