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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Documents

GenSure Biotech Inc.

Certificate V76 126886 0003

Rev. Rev. 00Issued
Valid until
Jul 15, 2030

Certificate V76 126886 0003 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 0003
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 0003Rev. 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

  • LH Ovulation Rapid Test
    697683823P201100DZ

Documents

LanguagesEN

Manufacturer

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

Covered devices

  • LH Ovulation Rapid TestIVDR Class B
    697683823P201100DZ