CE Certificates
1Pages

Tax Identification Number RO 13881247 Trade Register Office Number: J24/283/2001 Registered Office : Village of Ruscova, St. Principals no. 698, Maramures County, post code 437260 Place of business: Commune of Leordina, St. Principala no. 772, Maramures county Phone: 0745 959 441, E-mail: office@elimedical.ro website: www.elimedical.ro a) To keep the technical documentation describing the componence and the product development process and this Declaration of Conformity for a period of 5 years after the last product in the lot has been manufactured. b) To establish and maintain up to date a systematic procedure for capitalizing on the experience in the post-production stage; to implement the appropriate measures and to apply all and any necessary corrective action, taking into account the nature and risks related to the product; c) To communicate to the relevant Regulatory Authorities - National Agency for Medicines and Medical Devices, as soon as we become aware of: - any malfunction or deterioration of the characteristics or performance of the devices; - any inadvertence in labelling or instructions for use that could endanger life / cause severe deterioration of health; - any technical or functional reason, which led to the systematic withdrawal from the market of our products, for the reasons described above;