GenSure Biotech Inc.

Certificate V76 126886 0004

Rev. Rev. 00Issued

Valid until: Jul 15, 2030

Certificate V76 126886 0004 is a valid Technical documentation issued to GenSure Biotech Inc. and registered in EUDAMED. Valid until July 15, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: V76 126886 0004
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V76 126886 0004Rev. 00

Validity

Issued: Jul 16, 2025
Valid from: Jul 16, 2025
Valid until: Jul 15, 2030

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
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

Unspecified1

1 scope

HCG Pregnancy Rapid Test
697683823P201600ES

Documents

LanguagesEN