EryDel has a certified quality system which meets with the requirements of the standard EN ISO 13485:2016 (Certificate no. Q5 073611 0007).
Furthermore, according to the European Medical Devices Directive 93/42, and subsequent updates, the TÜV SÜD Group (EC 0123) Notified Body, issued the Certificate no. G1 073611 0005 which entitles to design, develop, produce and distribute blood processing disposable and equipment.
Current EryDel’s CE marked medical devices:
1. Red Cell Loader Electromedical Device
2. EryKit_01 and process solutions