Quality is the main priority on the medical devices market. It is also our priority. We know that thanks to our high quality products health-care personnel and patients can feel safety.
Since the beginning, we have maintained and improved the quality management system in accordance with PN-EN ISO 13485:2003 and CAN /ISO 13485:2003 rules.
Scope of these certificates includes designing, manufacturing, testing and supply of safety and personal lancets.
Our products are marked with label CE 0344 conforming with 93/42/ EEC directive requirements for medical devices. DEKRA is our certificating entity (http://www.dekra-certification.com).
Our products are registered on American and Japanese market.
Quality certificates of HTL-STREFA S.A.
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EN ISO 13484:2003 | CAN/CSA ISO 13485:2003 |
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| CE 0344 |
