Hangzhou Alltest Biotech.Co.,Ltd.

Certificate EU-QMS-FI-08820-800081-2026

Rev. 2Issued

Valid until: Apr 16, 2031

Certificate EU-QMS-FI-08820-800081-2026 is a valid Quality management system issued to Hangzhou Alltest Biotech.Co.,Ltd. and registered in EUDAMED. Valid until April 16, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: EU-QMS-FI-08820-800081-2026
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-08820-800081-20262

Validity

Issued: Apr 23, 2026
Valid from: Apr 23, 2026
Valid until: Apr 16, 2031

Notified body

Notified body: Sertio Oy
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: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C2

2 scopes

W0105 + IVP 3007
IVDR Class C
W0102 + IVP 3007
IVDR Class C

Documents

LanguagesEN