52 We are your partner for high-quality medical products In 2021, we successfully introduced a quality management system for medical products compliant with EN ISO 13485:2016 throughout the entire value-added chain. This means that Kerbl is now able to independently market class 1 medical products. The quality management system ensures that our products comply with EU Directive 2017/745 and therefore meet the high quality and reliability requirements for medical products across the whole of Europe. Kerbl has since been registered in the EUDAMED European database for medical products as a manufacturer (SRN No.: DE-MF000007708) and in the German Medical Device Information System (MPS) of the Federal Institute for Drugs and Medical Devices (BfArM) and implements the required measures: • Registration • Regular audits in the production facilities and at Albert Kerbl GmbH • Documentation of the quality inspection of each individual batch in the production sites and at KERBL • Consistent batch tracking from production to the customer • Introduction of complaints management for medical products „Medical products“ are characterised by the fact that they are „used on humans“. They are not „medicines“. Dealers do not require their own quality assurance system for medical products; the usual dealer obligations (e.g. product safety), which must also be complied with for other products, apply. Kerbl has been a dealer of medical products, such as needles, Roux revolvers, scalpel blades, eye rinse solutions, etc., for many years. Since 2021, we have been able to operate as a manufacturer of medical products too. Medical products are marked with the MD symbol („Medical Device): Examples: QM contact („Medical products consultant“): Robert Numberger (Tel. +49 8086 933 124, e-mail: Robert.Numberger@kerbl.com) Sales contact: Manuel Neubauer (Tel. +49 8086 933 483, E-mail: Manuel.Neubauer@kerbl.com) Class I Class IIa Class IIb Class III Medium risk, invasive e.g. disposable syringes, hearing aids High risk e.g. cardiac catheters, artificial joints Increased risk, invasive e.g. defibrillators, ventilators Low risk, superficial use e.g. disposable gloves, medical masks
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