Roland Consult Stasche & Finger GmbH

Roland Consult Stasche & Finger GmbH specializes in electrooculograph and electroretinograph devices. These systems are used to measure electrical activity in the eye, helping clinicians assess conditions related to vision and ocular health. Examples include models like the RETI-port/scan 21 series, which are designed for diagnostic purposes in ophthalmology.

The company is based in the United States. While the name suggests a German origin, the manufacturer’s operational headquarters and regulatory presence are established within the U.S. market.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for traceability and compliance tracking under U.S. regulations.

The company’s devices fall under Class II classification. This classification indicates they are subject to special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance requirements.

The FDA’s UDI database is a requirement for Class II devices in the U.S. to improve device tracking, reduce medical errors, and enhance transparency in the supply chain. Listing ensures that each device—such as the RETI-port/scan models—can be uniquely identified, monitored, and recalled if necessary, while meeting regulatory compliance.