GE Medical Systems Information Technologies, Inc.

Certificate HZ 2214580-1

Rev. 4Supplemented

Valid until: Oct 30, 2030

Certificate HZ 2214580-1 is a valid Quality management system issued to GE Medical Systems Information Technologies, Inc. and registered in EUDAMED. Valid until October 30, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2214580-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2214580-14

Validity

Issued: May 14, 2026
Valid from: May 14, 2026
Valid until: Oct 30, 2030

Manufacturer

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2214580-1Quality management systemReissuedOct 31, 2025 → Oct 30, 2030

Scope coverage

Class IIa2Class IIb1

3 scopes

Z120503 - ELECTROCARDIOGRAPHS
Class IIa
Z120507 - CARDIOGRAPHY INSTRUMENTS
Class IIa
Z120302 – INSTRUMENTS TO SUPPORT AND MONITORING VITAL SIGNS VITAL SIGNS MONITORING INSTRUMENTS
Class IIb

Documents

LanguagesEN