Xiamen Compower Medical Tech. Co., Ltd.

Certificate HZ 2375149-1

Rev. 0Issued

Valid until: Oct 12, 2028

Certificate HZ 2375149-1 is a valid Quality management system issued to Xiamen Compower Medical Tech. Co., Ltd. and registered in EUDAMED. Valid until October 12, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2375149-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2375149-10

Validity

Issued: Oct 13, 2023
Valid from: Oct 13, 2023
Valid until: Oct 12, 2028

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
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: 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: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

R030101 - VENTILATION MASKS R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS R030201 - VENTILATION BALLOONS R030202 - MANUALLY OPERATED VENTILATION BALLOONS
Class IIa

Documents

LanguagesEN