GenSure Biotech Inc.

Certificate V13 126886 0002

Rev. Rev. 00Issued

Valid until: Jul 15, 2030

Certificate V13 126886 0002 is a valid Quality management system 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: V13 126886 0002
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: 0123V13 126886 0002Rev. 00

Validity

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

Manufacturer

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

Notified body

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

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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C1IVDR Class B1

2 scopes

IVR 0503 - Infectious agent detection: Presence of, or exposure to an infectious agent including sexually transmitted agents
IVDR Class C
IVR 0607 - Physiological status and therapeutic measures: Pregnancy or fertility testing
IVDR Class B

Documents

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