Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Certificate CN24/00005514

Rev. 2Issued

Valid until: Aug 29, 2029

Certificate CN24/00005514 is a valid Quality management system issued to Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and registered in EUDAMED. Valid until August 29, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: CN24/00005514
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639CN24/000055142

Validity

Issued: Sep 30, 2024
Valid from: Sep 30, 2024
Valid until: Aug 29, 2029

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: Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

MDA0306 EMDN:Z120301
Class IIb
Anaesthetic Vaporizer Model V60, model V80, Model V90
Class IIb
Anesthesia system Model A8, A8C, A8pro, A80, A9, A9C, A9pro, A90C
Class IIb
Anesthesia System for inhaling anesthesia and respiration management
Class IIb

Documents

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