Nanjing Vazyme Medical Technology Co.,Ltd.

Certificate EU-QMS-FI-01219-800033-2025

Rev. 2Issued

Valid until: Dec 9, 2030

Certificate EU-QMS-FI-01219-800033-2025 is a valid Quality management system 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-QMS-FI-01219-800033-2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 3018EU-QMS-FI-01219-800033-20252

Validity

Issued: Dec 12, 2025
Valid from: Dec 12, 2025
Valid until: Dec 9, 2030

Manufacturer

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
Manufacturer country: China

Notified body

Notified body
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: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1

1 scope

IVR 0503 W0105-Infectious diseases
IVDR Class B

Documents

LanguagesEN