WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

Certificate HX 2055510-1

Rev. 2Amended

Valid until: Mar 21, 2029

Certificate HX 2055510-1 is a valid Quality management system issued to WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. and registered in EUDAMED. Valid until March 21, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2055510-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 2
Certificate ID: 0197HX 2055510-12

Validity

Issued: Jul 1, 2025
Valid from: Jul 1, 2025
Valid until: Mar 21, 2029

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: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

HX 2055510-1Quality management systemIssuedMar 22, 2024 → Mar 21, 2029

Scope coverage

IVDR Class C1

1 scope

CLINICAL CHMIESTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010606 - ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC
IVDR Class C

Documents

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