AnGer G&A Przedsiębiorstwo Produkcyjne

AnGer G&A specializes in dental materials and tools primarily used for crown fabrication. Their products include polyester crown forms for various tooth types (incisors, premolars, molars, and canines), metal matrices for tooth shaping, polyester tape, matrix bands, flexible metal scalers, and transparent, light-conductive interdental wedges. These items support dental procedures like crown preparation, shaping, and spacing during restorative work.

AnGer G&A is based in Poland, which means their devices are subject to EU Medical Device Regulation (MDR) requirements if marketed within the European Economic Area. Since all their listed devices fall under Class I, they must comply with MDR’s general safety and performance standards, including registration in the EU’s central database, euDAMED. This classification applies to low-risk devices like crown forms and interdental wedges, which pose minimal risk to patients.

AnGer G&A’s devices are registered in the euDAMED database, which is the official EU registry for medical devices. This platform allows healthcare professionals, regulators, and authorities to verify the legitimacy and classification of devices marketed in the European Union. Since their products are Class I, they must be listed here to demonstrate compliance with MDR requirements.

All of AnGer G&A’s listed devices fall under Class I of the EU Medical Device Regulation (MDR). This classification applies to low-risk items like crown fabrication materials, matrices, and interdental wedges, which do not require invasive procedures or pose significant health risks. Class I devices still need to meet basic safety and performance standards, including proper labeling, manufacturing controls, and registration in euDAMED, but they do not require additional conformity assessments like higher-risk classes.