Nanjing Vazyme Medical Technology Co.,Ltd.

Certificate EU-TDA-FI-66922-800033-2025

Rev. 3Issued

Valid until: Dec 9, 2030

Certificate EU-TDA-FI-66922-800033-2025 is a valid Technical documentation issued to Nanjing Vazyme Medical Technology Co.,Ltd. and registered in EUDAMED. Valid until December 9, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-TDA-FI-66922-800033-2025
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 3018EU-TDA-FI-66922-800033-20253

Validity

Issued: Jan 20, 2026
Valid from: Jan 20, 2026
Valid until: Dec 9, 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: No
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

Unspecified2

2 scopes

Quality Control Kit for Logilet Respiratory Pathogen Panel
6973315734875B3
Logilet Respiratory Pathogen Panel
6973315734882AY

Documents

LanguagesEN