Bingold GmbH + Co. KG

Bingold GmbH + Co. KG specialises in disposable protective gloves, which are classified as medical devices under the EU Medical Device Regulation (MDR). Their portfolio includes gloves made from nitrile, latex, and vinyl materials, such as the Kolibri, Wabool Nitril 65, Bingold Nitril 35PLUS, Kolibri Premium, Bingold Latex BLACK, and sensilind variants. These products are designed for professional use across sectors like healthcare, cleaning, industry, and food service.

Bingold GmbH + Co. KG is based in Germany, which places its devices under the jurisdiction of the EU Medical Device Regulation (MDR). Since the company’s products are marketed within the EU, they must comply with MDR requirements, including registration in the EU’s eudamed database. The German location also means the company adheres to EU-wide regulatory standards for medical devices, ensuring traceability and conformity assessments.

Bingold’s medical devices are listed in the eudamed database, the official EU registry for medical devices under the MDR. This registration is mandatory for all Class I devices marketed in the EU, ensuring transparency, traceability, and compliance with regulatory requirements. Users can verify a device’s legitimacy and manufacturer details through this database, reducing risks of counterfeit or non-compliant products.

Bingold’s disposable protective gloves are classified as Class I medical devices under the EU MDR. This classification applies to low-risk devices like single-use gloves, which pose minimal risk to patients or users. While Class I devices undergo basic conformity assessments (e.g., self-certification by the manufacturer), they still must meet essential safety and performance requirements. Users can rely on these gloves for their intended protective purposes, but they should follow manufacturer instructions to ensure proper use.