Change Healthcare Canada Company

Certificate US26/00000269

Rev. 1Issued

Valid until: Jun 17, 2031

Certificate US26/00000269 is a valid Quality management system issued to Change Healthcare Canada Company and registered in EUDAMED. Valid until June 17, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: US26/00000269
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639US26/000002691

Validity

Issued: Jun 17, 2026
Valid from: Jun 17, 2026
Valid until: Jun 17, 2031

Manufacturer

Manufacturer: Change Healthcare Canada Company
Manufacturer SRN: CA-MF-000032718
Manufacturer country: Canada

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa7Class IIb2

9 scopes

MDA0315, MDS1009, MDS1010
Class IIa
MDA0315, MDS1009, MDS1010, EMDN Code:Z1203020292
Class IIb
Change Healthcare Radiology Solution
Class IIa
Change Healthcare Enterprise Viewer
Class IIa
Change Healthcare Stratus Imaging Viewer
Class IIa
Change Healthcare Stratus Imaging PACS
Class IIa
Change Healthcare Cardiology
Class IIa
Change Healthcare Diagnostic Viewer
Class IIa
Change Healthcare Cardiology Hemodynamics
Class IIb

Documents

LanguagesEN