ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Certificate EU-TDA-FI-20642-800030-2025-1

Rev. 9Supplemented

Valid until: Mar 21, 2030

Certificate EU-TDA-FI-20642-800030-2025-1 is a valid Technical documentation issued to ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD and registered in EUDAMED. Valid until March 21, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-TDA-FI-20642-800030-2025-1
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 9
Certificate ID: 3018EU-TDA-FI-20642-800030-2025-19

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Mar 21, 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: 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

Supplemented

Supersedes

EU-TDA-FI-20642-800030-2025-1Technical documentationSupplementedApr 28, 2026 → Mar 21, 2030

Scope coverage

Unspecified6

6 scopes

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)
69520627J034LD
InfluenzaA+B&COVID-19 (SARS-CoV-2)Antigen Test Kit（Colloidal Gold）
69520627J017LD
COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
69520627J012L3
H.Pylori Antigen Test Kit
69520627J016LB
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)
69520627J161LM
COVID-19& Influenza A+B & RSV Antigen Combo Test Kit (LFA)
69520627J163LR

Documents

LanguagesEN