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Eko Devices, Inc.

US

Last updated May 23, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
079670921

Catalogue (24)

DeviceModel / ReferenceRegistriesClassStatus
Eko App Windows 1.2.4
FDA UDI
Class IActive
Eko Core Electronic Stethoscope Model E4
FDA UDI
Class IIActive
Eko Mobile App Android International com.ekodevices.android.intl
FDA UDI
Class IActive
Eko CORE 500 and CAC500 Standard bundle COR501
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Amethyst Bundle E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Sapphire Bundle E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Bundle-CHP E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Black Bundle E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Incase Bundle (Black) E8
FDA UDI
Class IIActive
EMAS (Eko Murmur Analysis Software) Version 1.x
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Incase Bundle E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Champagne Bundle E8
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Bundle-SLV E8
FDA UDI
Class IIActive
ELEFT (Eko Low Ejection Fraction Tool) v7.x
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Bundle-BLK E8
FDA UDI
Class IIActive
Eko Core Attachment Model E4
FDA UDI
Class IIActive
Duo E5
FDA UDI
Class IIActive
Eko CORE 500 Founder's Edition Chestpiece COR500FE
FDA UDI
Class IIActive
Eko CORE 500 and CAC500 Founder's Edition bundle COR501FE
FDA UDI
Class IIActive
CORE 500 Digital Stethoscope - Wintergreen Bundle E8
FDA UDI
Class IIActive
Eko CORE K200776
FDA 510(k)
Class IIActive
Eko Murmur Analysis Software (EMAS) K213794
FDA 510(k)
Class IIActive
Eko Electronic Stethoscope System K151319
FDA 510(k)
Class IIActive
Eko Model E5 System (EME5), Eko DUO K170874
FDA 510(k)
Class IIActive

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