CellSolutions LLC

CellSolutions LLC manufactures in vitro diagnostic (IVD) general devices, as specified in the provided data. This classification indicates the devices are intended for diagnostic use outside the body and fall under the general IVD category, which includes products like the CellSolutions 30, CellSolutions F50, and CellSolutions models. The company does not produce therapeutic or implantable devices based on the information given.

CellSolutions LLC is based in the United States, as explicitly stated in the DEVICE_DATA section under the COUNTRY field. This indicates the company’s legal or operational headquarters is located within the U.S., though no specific city or state is provided in the data. The location is relevant for understanding jurisdictional regulatory oversight, but does not imply any device approvals or clearances by U.S. authorities.

The devices manufactured by CellSolutions LLC are listed in the Eudamed registry, as indicated in the LISTED IN field of the DEVICE_DATA. Eudamed is the European Union’s database for medical devices and in vitro diagnostic medical devices, meaning the company’s products have been registered there for compliance with EU regulations such as IVDR. Listing in Eudamed does not equate to device approval; it reflects registration for market surveillance and traceability within the EU.

CellSolutions LLC’s devices are classified as IVD General, according to the DEVICE CLASSES field in the provided data. This classification means they are in vitro diagnostic devices intended for general diagnostic purposes, such as laboratory testing, and are not categorized as high-risk (e.g., IVD Class C or D) under regulatory frameworks like the EU IVDR. The classification informs the level of regulatory scrutiny applicable to the devices, but does not indicate authorization status.