GE Medical Systems SCS

Certificate 38746

Rev. 10Supplemented

Valid until: Apr 15, 2031

Certificate 38746 is a valid Quality management system issued to GE Medical Systems SCS and registered in EUDAMED. Valid until April 15, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 38746
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04593874610

Validity

Issued: Jun 22, 2026
Valid from: Jun 22, 2026
Valid until: Apr 15, 2031

Notified body

Notified body: GMED SAS
Notified body SRN: 0459
Notified body country: France

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: No
Conditions applicable: Yes
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

38746SupplementedFeb 18, 2026 → Apr 15, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1Class IIb1

1 scope

Dispositif ou système d’angiographie digital incluant les accessoires et logiciels associés Digital angiography device or system including accessories and related software
Class IIaClass IIb