KESEM HEALTH PTY LTD

Address:5A Hartnett Close,Mulgrave Victoria,AU

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Uroflowmeter (EXY) (1)

Premarket Exempt

Yes

Clear

iUFlow - B408IF20 Catalog Number :

Device Description : A uroflowmeter for measurement of urination (voiding) frequency, volume and flow A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow mobile application.

Device Class : 2

Duns Number: 743967162

Premarket Exempt : Yes

Product Code : EXY

Prescription Use : Yes

Device Count : 1

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