GERUI MEDICAL PRODUCTS CO., LTD.

Certificate HZ 2074285-1

Rev. 0Issued

Valid until: Jun 2, 2030

Certificate HZ 2074285-1 is a valid Quality management system issued to GERUI MEDICAL PRODUCTS CO., LTD. and registered in EUDAMED. Valid until June 2, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2074285-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2074285-10

Validity

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

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: No
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 I1

1 scope

V0402 - CLINICAL USE TRAYS AND BOWLS
Class I

Documents

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