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Legal/Regulatory Information PhysioFlow® is manufactured to ISO 9001/13485 standards and received FDA market clearance in 2008. In addition to U.S. clearance, PhysioFlow® complies with the following standards: EN60601-1 (medical devices), EN66601-1-1 (medical systems), EN66601-1-2 (EM compatibility). PhysioFlow® is approved by the Japanese Ministry of Health (approval number 21200BZY00563000), the Taiwanese Ministry of Health and the Korean FDA. All PhysioFlow® products are CE marked in accordance with the 93/42/CEE directive concerning medical devices (class IIa). PhysioFlow® is manufactured in France in accordance with ISO9001 and ISO13485 standards. PhysioFlow® SM-ICG™ technology is patented in the USA, France, UK, Italy and Canada.
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