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Regulatory & Intellectual Property
Australia:
SIM
®
is a Class I TGA listed medical device
ARTG Entry: 140328
GMDN: 11588 Alarm, enuresis
Europe:
SIM
®
is a Class I medical device EU Representative: MedNet GmbH
USA:
SIM
®
is a Class II medical device 510k submission is in progress.
Intellectual Property
Our technology has been in development for a number of years and is protected by a substantial portfolio of intellectual property including 8 patent families and exclusive license to two patent families.
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Continence Assessment