Shenzhen Combei Technology Co.,Ltd.

Certificate HZ 2111011-1

Rev. 1Supplemented

Valid until: May 29, 2029

Certificate HZ 2111011-1 is a valid Quality management system issued to Shenzhen Combei Technology Co.,Ltd. and registered in EUDAMED. Valid until May 29, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2111011-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2111011-11

Validity

Issued: Nov 5, 2025
Valid from: Nov 5, 2025
Valid until: May 29, 2029

Manufacturer

Manufacturer: Shenzhen Combei Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016047
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

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

History

Status changes

Supplemented

Supersedes

HZ 2111011-1Quality management systemIssuedMay 30, 2024 → May 29, 2029

Scope coverage

Class IIa1

1 scope

Z12030205 - NON–INVASIVE BLOOD PRESSURE GAUGES R060101 - COLD NEBULISATION SYSTEMS
Class IIa

Documents

LanguagesEN