Jiangsu Medomics Medical Technology Co.,Ltd.

Certificate EU-QMS-FI-56364-800035-2025-1 1

Rev. 1Amended

Valid until: Jan 31, 2030

Certificate EU-QMS-FI-56364-800035-2025-1 1 is a valid Quality management system issued to Jiangsu Medomics Medical Technology Co.,Ltd. and registered in EUDAMED. Valid until January 31, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-QMS-FI-56364-800035-2025-1 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: 3018EU-QMS-FI-56364-800035-2025-1 1 1

Validity

Issued: May 27, 2025
Valid from: May 27, 2025
Valid until: Jan 31, 2030

Notified body

Notified body: Sertio Oy
Notified body SRN: 3018
Notified body country: Finland

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: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

EU-QMS-FI-56364-800035-2025-1Quality management systemIssuedJan 31, 2025 → Jan 31, 2030

Scope coverage

IVDR Class D2

2 scopes

IVR0503 W0105 Infectious diseases
IVDR Class D
SARS-CoV-2/FluA/FluB+ADV/ RSV Antigen Combo Rapid Test Kit (LFIA)
IVDR Class D

Documents

LanguagesEN