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CE mark
Cizeta Medicali products are Class I medical devices and satisfy the requirements of Directive 93/42 EEC and further amendments. |
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UNI EN ISO 9001 and UNI CEI EN ISO 13485
The Cizeta Medicali has a quality management system according to the regulations UNI EN ISO 9001 and UNI CEI EN ISO 13485. Through this certification, obtained in 2001, Cizeta Medicali is able to ensure highest quality standard of product and service. |
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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. |
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ASQUAL
Certification issued by Quality Association ASQUAL (France) which guarantees the correspondence of certified products to standards NF G30-102B guaranteeing their quality. |
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OEKO-TEX STANDARD 100
All medical stockings, A.T.E. stockings, arm sleeves and various compression segments are certified OEKO-TEX to ensure freedom from harmful substances in order to guarantee the health of our customers. |
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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.
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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.
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