Πιστοποιήσεις

CE MARK

Cizeta Medicali products are Class I medical devices and satisfy the requirements of MDR 2017/745.

UNI EN ISO 9001 and UNI CEI EN ISO 13485

CIZETA MEDICALI has a quality management system according to the regulations UNI EN ISO 9001 and UNI CEI EN ISO 13485. Through these certifications, obtained in 2001, CIZETA MEDICALI is able to ensure highest quality standard of product and service.

OEKO-TEX STANDARD 100

All the products manufactured by CIZETA MEDICALI are OEKO-TEX certified, to ensure the absence of harmful substances, to protect Patients' health.

FDA

The Food and Drug Administration (FDA) is an agency of the Department of health and human services of the United States. Cizeta Medicali products are accredited to the FDA which has the purpose of protecting health public, safety and efficacy.

RAL

Certification issued by the Hohenstein Research Institute (Germany) which guarantees the quality of the stockings through periodic tests in accordance with the rules RAL-GZ 387/1.

EUROCOM (European manufacturers federation for compression therapy and orthopedic devices)

Cizeta Medicali is a founding member of Eurocom, Association of European producers of medical stockings and orthopaedic products. Can only be member Eurocom companies producing medical stockings certificated RAL-GZ 387/1. The object of the Association is to promote the knowledge of the stocking quality certified RAL-GZ 387/1 to all the actors in the healthcare.

ASQUAL

Certification issued by Quality Association ASQUAL (France) which guarantees the correspondence of certified products to standards NF G30-102B guaranteeing their quality.

CFDA

China Food and Drug Administration (CFDA) is an agency of the Department of Health of the China. Certification issued by CFDA which guarantees the conformity of the certified products with the specifications of the YY/T 0853-2011 standards.