ShenZhen Bi-rich Medical Devices Co., Ltd

Certificate FI25/1008018

Rev. Issue 1Issued

Valid until: Nov 4, 2030

Certificate FI25/1008018 is a valid Quality management system issued to ShenZhen Bi-rich Medical Devices Co., Ltd and registered in EUDAMED. Valid until November 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI25/1008018
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI25/1008018Issue 1

Validity

Issued: Nov 5, 2025
Valid from: Nov 5, 2025
Valid until: Nov 4, 2030

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: Yes
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

EMDN: Z12159004 Oxygen concentrators
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN