GE Medical Systems CO. Ltd

Certificate HZ 2096373-1

Rev. Rev.4Reissued

Valid until: Jul 21, 2031

Certificate HZ 2096373-1 is a valid Quality management system issued to GE Medical Systems CO. Ltd and registered in EUDAMED. Valid until July 21, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2096373-1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2096373-1Rev.4

Validity

Issued: Apr 22, 2026
Valid from: Jul 22, 2026
Valid until: Jul 21, 2031

Manufacturer

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
Manufacturer country: China

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

Supersedes

HZ 2096373-1Quality management systemSupplementedApr 2, 2025 → Jul 21, 2026

Scope coverage

Class IIa1Class IIb1

2 scopes

Z110401 - ULTRASOUND SCANNERS Z110402 - ULTRASOUND PROBES
Class IIa
Z120301 - INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENTS Z120302 - INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS VITAL SIGNS MONITORING INSTRUMENTS
Class IIb

Documents

LanguagesEN