Contec Medical Systems Co., Ltd.

Certificate C633117

Rev. 1Amended

Valid until: Sep 19, 2030

Certificate C633117 is a valid Quality management system issued to Contec Medical Systems Co., Ltd. and registered in EUDAMED. Valid until September 19, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C633117
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 2460C6331171

Validity

Issued: Sep 19, 2025
Valid from: Sep 19, 2025
Valid until: Sep 19, 2030

Manufacturer

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

C6331117Quality management systemIssuedSep 19, 2025 → Sep 19, 2030

Scope coverage

Class IIa2

2 scopes

Color Doppler Ultrasound Diagnostic System
Class IIa
CMS1700B, CMS1700C
Class IIa

Documents

LanguagesEN