GE Medical Systems CO. Ltd

Certificate HZ 2096373-1

Rev. 3Supplemented

Valid until: Jul 21, 2026

Certificate HZ 2096373-1 — a Quality management system issued to GE Medical Systems CO. Ltd — is approaching its expiry. Valid until July 21, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2096373-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2096373-13

Validity

Issued: Apr 2, 2025
Valid from: Apr 2, 2025
Valid until: Jul 21, 2026

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2096373-1Quality management systemIssuedNov 2, 2023 → 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