HangZhou Biotest Biotech Co.,Ltd.

Certificate EU-QMS-FI-72717-800073-2026

Rev. 1Issued

Valid until: Feb 3, 2031

Certificate EU-QMS-FI-72717-800073-2026 is a valid Quality management system issued to HangZhou Biotest Biotech Co.,Ltd. and registered in EUDAMED. Valid until February 3, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-QMS-FI-72717-800073-2026
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-72717-800073-20261

Validity

Issued: Feb 3, 2026
Valid from: Feb 3, 2026
Valid until: Feb 3, 2031

Manufacturer

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
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: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C2

2 scopes

IVR 0503 W0105 Infectious diseases
IVDR Class C
COVID-19 + Flu A&B + RSV+ Adenovirus Antigen Combo Rapid Test Cassette (Nasal Swab)
IVDR Class C

Documents

LanguagesEN