ACTO GmbH

ACTO GmbH specializes in dental and oral hygiene solutions. Their portfolio includes antiseptic mouthwashes like Actosept AF and Actosept AF Citrus, disinfectant gels such as Aclind w Gel, dental instrument cleaning solutions like Actodent Bohrerbad, antiseptic sprays including Actoanid Spray, and specialized rinses for oral care procedures such as Actosed OPA and Actosed PA Solution. These products are designed for use in dental practices and oral healthcare settings.

ACTO GmbH is headquartered in Wietzen-Holte, Germany, with additional operational locations in Braunschweig, Bavaria, and Baden-Württemberg. Their devices are listed in the EU’s official medical device registry, eudamed, where regulatory details such as classification and device identification can be verified. This database is the primary source for tracking authorized medical devices within the European Union.

ACTO GmbH’s devices are classified under the EU Medical Device Regulations (MDR) based on their intended use and associated risks. Their products fall into Class I (low-risk, non-invasive items like some oral rinses), Class IIa (moderate-risk devices such as certain antiseptic solutions), Class IIb (higher-risk items like specialized dental cleaning agents), and Class III (high-risk devices, if applicable). Classification determines regulatory requirements, including clinical evaluation and conformity assessment procedures.

Based on the available information, ACTO GmbH’s devices are registered in the eudamed database, which is the EU’s central registry for medical devices. While some manufacturers may also appear in national registries or other databases depending on market access, eudamed is the primary EU-wide source for tracking these products. For comprehensive global visibility, additional registries may apply outside the EU, but those details are not specified here.