EryDel has a certified quality system which meets with the requirements of two standards: EN ISO 13485:2003 / AC-2007 and ISO 9001:2008 (Certificate no. Q1N 10 06 73611 001 and Certificate UNI EN ISO 9001:2008 no. 50 100 9778 - Rev. 01)
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 10 06 73611 002 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