Copan Wasp Srl

Copan Wasp Srl specializes in instruments for microbial specimen handling, including automated systems for inoculating, streaking, and picking bacterial colonies. Their portfolio also includes pipetting systems designed specifically for in vitro diagnostic (IVD) applications. These devices are engineered to improve efficiency and precision in microbiology laboratory workflows.

Copan Wasp Srl is based in the United States, which means its devices are subject to FDA regulatory oversight. The company’s products are listed in the FDA’s databases, including submissions like 510(k) clearances and De Novo requests, reflecting compliance with U.S. regulatory requirements for medical devices.

Copan Wasp Srl’s devices are included in the FDA’s regulatory databases under 510(k) clearances and Unique Device Identifier (UDI) listings. These registries document the classification and submission history of their products, ensuring transparency in their regulatory status.

Copan Wasp Srl’s devices are classified under both FDA Class I and Class II categories. Class I generally covers low-risk devices requiring general controls, while Class II includes moderate-risk devices that may require additional performance standards or special controls. The classification depends on factors like the device’s intended use and potential risks.

Copan Wasp Srl has submitted 510(k) clearances and De Novo requests to the FDA for its devices. A 510(k) demonstrates that a new device is substantially equivalent to a legally marketed predicate device, while a De Novo request is used for devices that do not have a predicate and require classification through a scientific review.