Anrei Medical (HZ) Co., Ltd.

Certificate G15 086239 0021

Rev. Rev. 00Issued

Valid until: Dec 2, 2030

Certificate G15 086239 0021 is a valid Quality management system issued to Anrei Medical (HZ) Co., Ltd. and registered in EUDAMED. Valid until December 2, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 086239 0021
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 086239 0021Rev. 00

Validity

Issued: Dec 3, 2025
Valid from: Dec 3, 2025
Valid until: Dec 2, 2030

Manufacturer

Manufacturer: Anrei Medical (HZ) Co., Ltd.
Manufacturer SRN: CN-MF-000009964
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2Class IIb1

3 scopes

G030202 - DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS
Class IIb
MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
Class IIa
MDN 1208 - Non-active non-implantable instruments
Class IIa

Documents

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