Qingdao Wearable Intelligent Medical Co.,Ltd.

Certificate HZ 2565917-1

Rev. Rev.0Issued

Valid until: Jun 21, 2031

Certificate HZ 2565917-1 is a valid Quality management system issued to Qingdao Wearable Intelligent Medical Co.,Ltd. and registered in EUDAMED. Valid until June 21, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2565917-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2565917-1Rev.0

Validity

Issued: Jun 22, 2026
Valid from: Jun 22, 2026
Valid until: Jun 21, 2031

Manufacturer

Manufacturer: Qingdao Wearable Intelligent Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000042663
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: 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 IIa1

1 scope

Products of class IIa: Z12050301 - GENERAL PURPOSE ELECTROCARDIOGRAPHS
Class IIa

Documents

LanguagesEN