FRESCO holds the Medical Manufacturer Licence 7521-PS as a manufacturer audited by the Spanish Agency for Medical Devices and Pharmaceuticals.

Additionally Fresco complies with latest Quality Management standards. Including ISO 9001:2015, ISO 13485:2016 (medical devices) and ISO 22716:2007 (cosmetic products).

Our polymer gel complies with the CE regulations for biological evaluation of medical devices according to ISO 10993.

Biocompatibility & ISO 10993 Medical Device Test

Skin irritation test: ISO 10993-10
Analysis of intracutaneous reactivity: ISO 10993-10
Skin sensitisation study: Buehler test in compiliance with UNE-EN iSO 10993-109
Citotoxicity assay: ISO 10993-5

All Fresco’s manufactured medical products have CE marking.
The company is FDA registered.