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 Quality StandardsUnomedical is committed as a local manufacturer to provide cost effective, quality products for the improvement, treatment and safe care of patients and health care professionals. Our production facility is in compliance with FDA 21CFR PART 820 requirements and holds certification to ISO 9001:2000, ISO 13485:2003, ISO 13485:2003 CMDR quality system standards. The company has further been assessed and found to meet the requirements of the European Medical Device Directive 93/42/EEC and products carry the CE mark. We are committed to supplying products that meet and exceed customer needs and expectations by using cost efficient production systems and processes. The world wide knowledge resources of the Unomedical group helps us as a local manufacturer to operate to the highest international standards of manufacturing quality. Latex ContentWe know that the subject of latex and latex allergy is a topic of great importance. For this reason, the majority of the products we make available are latex free. However, we do have exceptions containing natural rubber such as latex foley catheters but also here we offer a non-latex alternative made of 100% silicone.
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