Shanghai SurgEx Medical Co., Ltd

Certificate 284/MDR

Rev. 1Issued

Valid until: May 13, 2031

Certificate 284/MDR is a valid Quality management system issued to Shanghai SurgEx Medical Co., Ltd and registered in EUDAMED. Valid until May 13, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 284/MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051284/MDR1

Validity

Issued: May 14, 2026
Valid from: May 14, 2026
Valid until: May 13, 2031

Manufacturer

Manufacturer: Shanghai SurgEx Medical Co., Ltd
Manufacturer SRN: CN-MF-000051083
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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 IIb1

1 scope

Apparecchi al plasma per elettrochirurgia e relativi elettrodi monouso / Plasma electrosurgical equipment and related disposable electrodes
Class IIb

Documents

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