Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Certificate MDR 757840

Rev. R001Supplemented

Valid until: Oct 20, 2027

Certificate MDR 757840 is a valid Quality management system issued to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and registered in EUDAMED. Valid until October 20, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 757840
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 757840R001

Validity

Issued: Jun 4, 2026
Valid from: Jun 4, 2026
Valid until: Oct 20, 2027

Manufacturer

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

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

History

Status changes

Supplemented

Supersedes

MDR 757840SupplementedJun 12, 2025 → Oct 20, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb4Class IIa4Class III2

10 scopes

Mechanical Chest Compression System
Class IIb
Remote Control System
Class IIb
Disposable Defibrillation Electrode
Class IIb
High Flow Humidified Oxygen Delivery System and related non-sterile accessories
Class IIb
CPR sensor
Class IIa
CO2 sensor
Class IIa
Nasal cannula
Class IIa
Humidification Chamber
Class IIa
Automated External Defibrillator
Class III
Defibrillator/Monitor
Class III

Documents

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