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Regulatory Compliance

CAL PROP 65
GS1 | PEPPOL
GDPR
HIPAA | HITECH
EU MDR Manufacturer Declaration
EU 2023-607/901541 BSI

DEKRA EC Certificate 2021603CE02
for Sierra Summit, Arc Essentia, Arc Apollo, Arc Zenith, ApneaTrak

DEKRA CE / BSI AR120 816664

DEKRA EC Certificate 2021603CE04
for Cascade IOMAX

DEKRA CE / BSI AR120 816746
BSI ISO 13485:2016
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