What clearances do Eko products have?
Are Eko products HIPAA compliant?
Can Eko products be used for telemedicine, virtual, or home care?
|
Clearance |
Eko products |
Location |
|---|---|---|
|
FDA |
|
United States |
|
CE |
|
European Union |
|
Health Canada |
|
Canada |
|
TGA (Australia) |
|
Australia |
|
MDSAP |
Eko has been audited per the requirements of the Medical Device Single Audit Program (MDSAP). |
N/A |
|
ISO 13485:2016 |
Eko maintains an ISO 13485 certified Quality Manufacturing System. |
N/A |
|
Brazilian Health Regulatory Agency ANVISA |
|
Brazil |
Eko stethoscopes and software are purpose-built for telemedicine. Eko supports virtual care or telehealth programs for individual providers, small clinics, and multi-site hospitals. A subscription may be required for telemedicine live streaming.