Medcem GmbH

Medcem GmbH specializes in endodontic materials, specifically those based on pure Portland cement. Their product range includes manual mixing systems like the MMTA 7g, MMTA 10, and MMTA 40, which require on-site preparation before use. They also produce pre-mixed pastes, such as the MPPC 7g, MPPC 10, and MPPC 40, as well as dual-rinse chelating agents (e.g., HEDP formulations in 10mL, 30mL, and 100mL volumes) designed for root canal treatment.

Medcem GmbH is headquartered in Switzerland, as indicated by its country designation (CH). The company’s location is relevant for understanding its regulatory framework and market focus, particularly within the European Union.

All of Medcem GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained under EU Medical Device Regulations (MDR) and allows stakeholders to verify device details, including manufacturer information, classifications, and UDI (Unique Device Identification) data.

Medcem GmbH’s devices fall under Class I and Class IIa classifications in the EU Medical Device Regulations. The classification determines the regulatory requirements for conformity assessment, labeling, and post-market surveillance. For example, Class IIa devices typically require additional scrutiny (e.g., clinical evaluation or notified body involvement) compared to Class I, reflecting their perceived risk level.