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Scientific Intake

US

Last updated May 23, 2026

Information

Country
US
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EUDAMED SRN
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FDA FEI Number
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Catalogue (4)

DeviceModel / ReferenceRegistriesClassStatus
SmartByte Device SI-001.01
FDA UDI
Class IIActive
SmartByte Palatal Impression Kit SI-004.01
FDA UDI
N/AActive
Sensor Monitored Alimentary Restriction Therapy (SMART) Device DEN150033
FDA 510(k)
Class IIActive
SmartByte Device K171165
FDA 510(k)
Class IIActive

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