Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Certificate CN23/00003444

Rev. 3Supplemented

Valid until: Jun 27, 2028

Certificate CN23/00003444 is a valid Quality management system issued to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and registered in EUDAMED. Valid until June 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CN23/00003444
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1639CN23/000034443

Validity

Issued: Jan 10, 2024
Valid from: Jan 10, 2024
Valid until: Jun 27, 2028

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

CN23/00003444Quality management systemSupplementedAug 16, 2023 → Jun 27, 2028

Scope coverage

Class IIb3Class IIa2

5 scopes

MDA0306, MDs1009, MDS1005
Class IIa
MDA0312 EMDN K020199
Class IIb
Electrosurgical Platform intended for use with monopolar and bipolar accessories for cutting and coagulating tissue
Class IIb
Fluid Management System (Model: HP100G, HP200G, HP200L, HP200D)
Class IIa
Ultrasonic Surgical and Electrosurgical Energy Platform
Class IIb

Documents

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