GenSure Biotech Inc.

Certificate V76 126886 0005

Rev. Rev. 00Issued

Valid until: Jul 10, 2030

Certificate V76 126886 0005 is a valid Technical documentation issued to GenSure Biotech Inc. and registered in EUDAMED. Valid until July 10, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: V76 126886 0005
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 0005Rev. 00

Validity

Issued: Jul 11, 2025
Valid from: Jul 11, 2025
Valid until: Jul 10, 2030

Manufacturer

Manufacturer
Manufacturer SRN: CN-MF-000028354
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

Strep A Rapid TestIVDR Class C
697683823P201900F9

Linked SSCPs

SSCP GS/TD-EU-P2019-901

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

Strep A Rapid Test
697683823P201900F9

Documents

LanguagesEN