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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name reusable intermittent urinary catheter system
De Novo Number DEN250023
Device Name Aurie System
Requester
cathbuddy, inc.
841 e. fayette st.
syracuse,  NY  13210
Contact souvik paul
Regulation Number876.5120
Classification Product Code
SHV  
Date Received06/06/2025
Decision Date 04/30/2026
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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