Wuxi Beien Surgery Device Co., Ltd.

Certificate HZ 2156300-1

Rev. 0Issued

Valid until: Jan 19, 2030

Certificate HZ 2156300-1 is a valid Quality management system issued to Wuxi Beien Surgery Device Co., Ltd. and registered in EUDAMED. Valid until January 19, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2156300-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2156300-10

Validity

Issued: Jan 20, 2025
Valid from: Jan 20, 2025
Valid until: Jan 19, 2030

Manufacturer

Manufacturer: Wuxi Beien Surgery Device Co., Ltd.
Manufacturer SRN: CN-MF-000017684
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: Yes
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

H020201 - LINEAR STAPLERS, OPEN SURGERY H020301 - LINEAR STAPLERS FOR VIDEOSURGERY Disposable Powered Endoscopic Stapler
Class IIa

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