Shenzhen Pango Medical Electronics Co., Ltd

Certificate 28620184373

Rev. 01Issued

Valid until: Jul 25, 2029

Certificate 28620184373 is a valid Quality management system issued to Shenzhen Pango Medical Electronics Co., Ltd and registered in EUDAMED. Valid until July 25, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 28620184373
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 28622862018437301

Validity

Issued: May 12, 2026
Valid from: May 12, 2026
Valid until: Jul 25, 2029

Manufacturer

Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd
Manufacturer SRN: CN-MF-000023018
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2862
Notified body country: Sweden

Covered devices

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa7

7 scopes

Devices for monitoring vital parameters
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
PG-X101 - Fingertip Pulse Oximeter
Class IIa
PG-X102 - Fingertip Pulse Oximeter
Class IIa

Documents

LanguagesEN