Jiangsu Medomics Medical Technology Co.,Ltd.

Certificate EU-TDA-FI-06912-800035-2025-1

Rev. 9Supplemented

Valid until: Jan 31, 2030

Certificate EU-TDA-FI-06912-800035-2025-1 is a valid Technical documentation 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-TDA-FI-06912-800035-2025-1
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 3018EU-TDA-FI-06912-800035-2025-19

Validity

Issued: Apr 10, 2026
Valid from: Apr 10, 2026
Valid until: Jan 31, 2030

Notified body

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

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: Yes
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

EU-TDA-FI-06912-800035-2025-1SupplementedMar 11, 2026 → Jan 30, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified1

1 scope

Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)
697416789123145ZT

Documents

LanguagesEN