Eko Health, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000034386 FEI 3011651230
- Devices
- 60
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
What Eko Health, Inc. makes
Eko Health produces digital stethoscopes, including chestpieces and earpieces for auscultation, alongside software tools for cardiac analysis. Their offerings include diagnostic software like the Eko Foundation Analysis Software with Transformers (EFAST) and the Eko Low Ejection Fraction Tool (ELEFT), designed to assist in evaluating heart function. The company also manufactures attachments for digital stethoscope systems, such as the CORE Digital Attachment.
The company’s devices are classified under FDA regulations as Class II and Class IIa, with some entries listed in the EU’s eudamed database. Authorisation for these products is obtained through FDA 510(k) clearance and EU regulatory pathways. The manufacturer is based in the United States.
Catalogue
Search and filter all 60 devicesCORE 500 Digital Stethoscope - Earpiece Ref CAC500_CBL
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Earpiece Ref CAC500_FDH
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Eko App Ref iOS v5.x
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Earpiece Ref CAC500_FMO
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Earpiece Ref CAC500_PNK
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Chestpiece Ref COR500_CHP
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Chestpiece Ref COR500_PNK
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Chestpiece Ref COR500_ROG
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Chestpiece Ref COR500_BLU
Regimes: CE MDR Registry: EUDAMEDGUDIDCORE 500 Digital Stethoscope - Earpiece Ref CAC500_BLK
Regimes: CE MDR Registry: EUDAMEDGUDID
Showing 51-60 of 60
Company details
- EUDAMED SRN
- US-MF-000034386
- FDA FEI number
- 3011651230
- DUNS number
- 079670921
- EU VAT number
- EU372013633
- EUDAMED status
- Active
- EUDAMED registered name
- Eko Health, Inc.
- Registered address
- 2100 Powell St, Suite 300, 94608, Emeryville, United States
- Website
- www.ekohealth.com
- [email protected]
- PRRC contact
- Taylor Gold West
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 10 Mar 2030
Eurofins Electric & Electronics Finland Oy 0537 1 certificate
- CR-03-1189-865-25 Active
Quality management system EU MDR
- Issued
- 10 Mar 2025
- Expires
- 10 Mar 2030