WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

Certificate IX 2055510-1

Rev. Rev.2Issued

Valid until: Mar 21, 2029

Certificate IX 2055510-1 is a valid Technical documentation 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: IX 2055510-1
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197IX 2055510-1Rev.2

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

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

Blood Gas Testing Cartridge
697372013BGBG001B4

Documents

LanguagesEN