GE HUALUN MEDICAL SYSTEMS CO. Ltd

Certificate HZ 2049089-1

Rev. Rev.4Supplemented

Valid until: Dec 5, 2026

Certificate HZ 2049089-1 — a Quality management system issued to GE HUALUN MEDICAL SYSTEMS CO. Ltd — is approaching its expiry. Valid until December 5, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2049089-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 2049089-1Rev.4

Validity

Issued: May 7, 2026
Valid from: May 7, 2026
Valid until: Dec 5, 2026

Manufacturer

Manufacturer
Manufacturer SRN: CN-MF-000001189
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

Status changes

Supplemented

Supersedes

HZ 2049089-1Quality management systemSupplementedAug 21, 2025 → Dec 5, 2026

Scope coverage

Class IIa1Class IIb1

2 scopes

Z110690 - VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS Z110201 - COMPUTERISED GAMMA CAMERAS
Class IIa
Z110311 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES Z110301 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS DIGITAL ANGIOGRAPHY SYSTEMS Z110202 - NUCLEAR MEDICINE INSTRUMENTS INTEGRATED CT/GAMMA CAMERA SYSTEMS
Class IIb

Documents

LanguagesEN