EryDel has CE Marked its New Medical Devices for automatic encapsulation of Drugs into Human Autologous Red Blood Cells

On 2010 the EryDel SpA company has established a quality system which meets the requirements of two standards: EN ISO 13485:2003 / AC-2007 and ISO 9001:2008. The certification was issued by the TÜV SÜD Group (EC 0123) Notified Body according to the European Medical Devices Directive 93/42, and subsequent updates, for the following purpose: design and development, production and distribution of disposable and equipment for blood processing.
EryDel also qualified medical devices by affixing the CE mark on its products.

Current medical devices CE marked by EryDel:

— Disposable (single use) Medical device (ERY-Kit family) dedicated to blood processing that may subsequently be reinfused to the same donor. More specifically, this is a disposable medical device that allows the encapsulation of Dexamethasone Sodium Phosphate inside red blood cells, that are used as biocompatible carriers and innovative route of administration. The device is non-toxic, non-pyrogenic, supplied sterile in individual package and sterilized with ethylene oxide.

— Electro-medical equipment (RED CELL LOADER family). Used in combination with the disposable family ERY-KIT, it is the non-invasive device, fully automatic and highly reproducible, that allows the loading of drugs and other biological agents within red blood cells.

Certifications

— CERTIFICATO CE no. G1 10 06 73611 002 » view

— CERTIFICATE no. Q1N 10 06 73611 001 » view

— CERTIFICATE UNI EN ISO 9001:2008 no. 50 100 9778 - Rev. 01 » view

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