ShenZhen Bi-rich Medical Devices Co., Ltd

Certificate CN25/00003166

Rev. 1Issued

Valid until: May 15, 2030

Certificate CN25/00003166 is a valid Quality management system issued to ShenZhen Bi-rich Medical Devices Co., Ltd and registered in EUDAMED. Valid until May 15, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: CN25/00003166
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639CN25/000031661

Validity

Issued: May 15, 2025
Valid from: May 15, 2025
Valid until: May 15, 2030

Notified body

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

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa5

5 scopes

MDA0307
Class IIa
MDA0307, MDS1009
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN