SG Healthcare Co.,Ltd

Certificate 2026-MDR/QS-026

Rev. 00Issued

Valid until: May 8, 2031

Certificate 2026-MDR/QS-026 is a valid Quality management system issued to SG Healthcare Co.,Ltd and registered in EUDAMED. Valid until May 8, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 2026-MDR/QS-026
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652026-MDR/QS-02600

Validity

Issued: May 8, 2026
Valid from: May 8, 2026
Valid until: May 8, 2031

Manufacturer

Manufacturer: SG Healthcare Co.,Ltd
Manufacturer SRN: KR-MF-000011322
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Mobile C-arm X-ray SystemClass IIb
880936528MCASB

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 IIb2

2 scopes

Fluoroscopy devices
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN