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BSI ISO 13485:2016 Certificate # FM 539204
BSI ISO 13485:2016 Certificate # MDSAP 689664
Health Canada Device License for
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# 78347
Health Canada Device License for
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# 87520
Health Canada Device License for
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# 93385
US FDA 510k for
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# K082628
US FDA 510k for
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# K111373
US FDA 510k for
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# K141480
BSI CE Certificate for
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# CE 539277
Australia TGA ARTG Certificate for
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# 177785
Brazilian ANIVSA for
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# 094337/14-1
South Korea KFDA for
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# 14-1334
Japan MHLW for
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# BG30200090
Taiwan FDA for
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# 032589
Singapore HSA for
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# DE0019287
Malaysia MDA for
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# 030577
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