Dongguan SIMZO Electronic Technology Co., Ltd.

Certificate CN25/00001354

Rev. 4Supplemented

Valid until: Mar 6, 2030

Certificate CN25/00001354 is a valid Quality management system issued to Dongguan SIMZO Electronic Technology Co., Ltd. and registered in EUDAMED. Valid until March 6, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: CN25/00001354
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 1639CN25/000013544

Validity

Issued: Jan 19, 2026
Valid from: Jan 19, 2026
Valid until: Mar 6, 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: No
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: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

CN25/00001354Quality management systemSupplementedSep 16, 2025 → Mar 6, 2030

Scope coverage

Class IIa7

7 scopes

MDA0307, MDS1009
Class IIa
MDA0203, MDS1009, MDS1010
Class IIa
DEVICE
Class IIa
Infrared Forehead Thermometer
Class IIa
Infrared Thermometer
Class IIa
Clinical Digital Thermometer
Class IIa
Compressor Nebulizer
Class IIa

Documents

LanguagesEN