GenSure Biotech Inc.

Certificate 6211186CE01

Rev. 0Issued

Valid until: Jan 1, 2031

Certificate 6211186CE01 is a valid Quality management system issued to GenSure Biotech Inc. and registered in EUDAMED. Valid until January 1, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 6211186CE01
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: 03446211186CE010

Validity

Issued: Jan 20, 2026
Valid from: Jan 20, 2026
Valid until: Jan 1, 2031

Manufacturer

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

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 C2

2 scopes

DEVICE
IVDR Class C
DEVICE
IVDR Class C

Documents

LanguagesEN