OCO-Präparate Herstellung und Vertrieb von pharmazeutischen Produkten GmbH

OCO-Präparate specializes in dental coatings and tooth-desensitizing agents. These include products like suspensions, syringes, pastes, and powders designed to protect cavities and relieve tooth sensitivity. Examples include formulations like CALXYL® Suspension and GINGIVA-SICCATIV, which target specific dental needs such as hypersensitivity and gingival drying.

The company is based in Germany, as indicated by its country designation (DE). This location aligns with its compliance requirements for EU medical device regulations.

The devices produced by OCO-Präparate are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations.

The company’s devices fall into Class I and Class IIa classifications under EU medical device regulations. Class I devices are generally low-risk, non-invasive products like dental coatings, while Class IIa includes those with a moderate risk, such as some desensitizing agents or radiopaque formulations (e.g., CALXYL® X-RAY VISIBLE). Classification determines regulatory requirements like labeling, post-market surveillance, and conformity assessment procedures.