MEDICAL SCIENTIFIC EQUIPMENT

This manufacturer specializes in laboratory centrifuges, which are used to separate biological samples by spinning them at high speeds. Their product line includes models like the Harrier, Kestrel, Hawk R, Falcon 6/300R, Cellsep 6/720R, Owl, Blue Force 12L R, and MicroCentaur R. These devices are designed for clinical, research, and industrial laboratories and come with various voltage and frequency compatibility options (e.g., 230V/50Hz, 400V/50-60Hz) to suit different environments.

The manufacturer is based in France. This location aligns with its compliance with European regulatory standards, particularly for devices marketed within the EU.

The manufacturer’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary conformity assessments and are intended for placement on the EU market.

The manufacturer’s centrifuges fall under Class A medical devices according to EU regulations. Class A devices are generally considered low-risk, requiring compliance with essential safety and performance standards but not full clinical evaluation or notifying bodies. This classification applies to their laboratory centrifuges, which are designed for routine use in controlled environments.