GE Healthcare Japan Corporation

Certificate HZ 2066093-1

Rev. 2Issued

Valid until: Dec 3, 2025

Certificate HZ 2066093-1, a Quality management system issued to GE Healthcare Japan Corporation, has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2066093-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2066093-12

Validity

Issued: Dec 5, 2023
Valid from: Dec 5, 2023
Valid until: Dec 3, 2025

Manufacturer

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
Manufacturer country: Japan

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: 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 IIa2Class IIb1

3 scopes

Z110306 - Computed Tomography Scanning Systems (CT)
Class IIa
Z110402 - Ultrasound Probes
Class IIa
Z110306 - Computed Tomography Scanning Systems (CT)
Class IIb

Documents

LanguagesEN