GenSure Biotech Inc.

Certificate 6211186TD01

Rev. 0Issued

Valid until: Jan 1, 2031

Certificate 6211186TD01 is a valid Technical documentation 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: 6211186TD01
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 03446211186TD010

Validity

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

Notified body

Notified body: DEKRA Certification B.V.
Notified body SRN: 0344
Notified body country: Netherlands

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
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

Unspecified2

2 scopes

COVID-19/RSV/Flu A+B Ag Rapid Test
697683823P208100FJ
COVID-19/Flu A+B Ag Rapid Test
697683823P200700EQ

Documents

LanguagesEN