Hangzhou Alltest Biotech.Co.,Ltd.

Certificate CN26/00001622

Rev. 1Issued

Valid until: Mar 10, 2031

Certificate CN26/00001622 is a valid Quality management system issued to Hangzhou Alltest Biotech.Co.,Ltd. and registered in EUDAMED. Valid until March 10, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: CN26/00001622
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: 1639CN26/000016221

Validity

Issued: Mar 10, 2026
Valid from: Mar 10, 2026
Valid until: Mar 10, 2031

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C5

5 scopes

IVR 0503, IVS 1002, IVP 3007, EMDN W0105
IVDR Class C
COVID-19/FLU A+B/RSV/Adenovirus Antigen Rapid Test
IVDR Class C
COVID-19/FLU A+B/RSV Antigen Rapid Test
IVDR Class C
COVID-19/Flu A+B Antigen Rapid Test
IVDR Class C
COVID-19 Antigen Rapid Test
IVDR Class C

Documents

LanguagesEN