Ingenetix GmbH

Certificate IQMS/00006/0v001

Rev. v001Issued

Valid until: Mar 2, 2031

Certificate IQMS/00006/0v001 is a valid Quality management system issued to Ingenetix GmbH and registered in EUDAMED. Valid until March 2, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IQMS/00006/0v001
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: 2962IQMS/00006/0v001v001

Validity

Issued: Mar 3, 2026
Valid from: Mar 3, 2026
Valid until: Mar 2, 2031

Notified body

Notified body: QMD Services GmbH
Notified body SRN: 2962
Notified body country: Austria

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: 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

IVDR Class D2

2 scopes

W0106 IVR0403
IVDR Class D
FetoGnost® Kit RHD
IVDR Class D

Documents

LanguagesEN