Eko Health, Inc.

Certificate CR-03-1189-865-25

Rev. 01Issued

Valid until: Mar 10, 2030

Certificate CR-03-1189-865-25 is a valid Quality management system issued to Eko Health, Inc. and registered in EUDAMED. Valid until March 10, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1189-865-25
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0537CR-03-1189-865-2501

Validity

Issued: Mar 10, 2025
Valid from: Mar 10, 2025
Valid until: Mar 10, 2030

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
Class IIa
CORE 500 Digital Stethoscope
Class IIa
Eko CORE Digital Stethoscope; Eko CORE Digital Attachment
Class IIa

Documents

LanguagesEN