Zhejiang Soudon Medical Technology Co.,Ltd

Certificate M.2025.MDR.1069

Rev. 01Supplemented

Valid until: Apr 7, 2029

Certificate M.2025.MDR.1069 is a valid Quality management system issued to Zhejiang Soudon Medical Technology Co.,Ltd and registered in EUDAMED. Valid until April 7, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2025.MDR.1069
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2025.MDR.106901

Validity

Issued: May 18, 2026
Valid from: May 18, 2026
Valid until: Apr 7, 2029

Manufacturer

Manufacturer: Zhejiang Soudon Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000021047
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2696
Notified body country: Croatia

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented
Supplemented

Supersedes

M.2025.MDR.1069Quality management systemIssuedApr 8, 2025 → Apr 7, 2029

Scope coverage

Class IIb2

2 scopes

Sterile, Disposable Polypectomy Snares BASIC UDI DI:697513704SN03L9
Class IIb
Sterile, Disposable Hemostatic Clips BASIC UDI DI: 697513704HC02G3
Class IIb

Documents

LanguagesEN