G. Heinemann Medizintechnik GmbH

(Product ENT-treatment units): (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (Product ENT-treatment units and ENT-diagnostic devices): (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(Product ENT-diagnostic devices): (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (Product ENT-treatment units and ENT-diagnostic devices): (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;