Beijing Wandong Medical Technology Co., Ltd.

Certificate HZ 2101256-1

Rev. 1Issued

Valid until: Jun 15, 2028

Certificate HZ 2101256-1 is a valid Quality management system issued to Beijing Wandong Medical Technology Co., Ltd. and registered in EUDAMED. Valid until June 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2101256-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2101256-11

Validity

Issued: Nov 30, 2023
Valid from: Nov 30, 2023
Valid until: Jun 15, 2028

Manufacturer

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class IIb1

2 scopes

Z110501 - MAGNETIC RESONANCE (MR) SYSTEMS
Class IIa
Z110301 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS DIGITAL ANGIOGRAPHY SYSTEMS Z110306 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS COMPUTED TOMOGRAPHS (CT) Z110311 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS DIRECT DIGITAL RADIOLOGY (DR) SYSTEMS Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES
Class IIb

Documents

LanguagesEN