Seramun Diagnostica GmbH

Certificate HX 1624072-1

Rev. Rev. 1Supplemented

Valid until: Oct 8, 2029

Certificate HX 1624072-1 is a valid Quality management system issued to Seramun Diagnostica GmbH and registered in EUDAMED. Valid until October 8, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1624072-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 2
Certificate ID: 0197HX 1624072-1Rev. 1

Validity

Issued: Oct 30, 2025
Valid from: Oct 30, 2025
Valid until: Oct 8, 2029

Manufacturer

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
Manufacturer country: Germany

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
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: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HX 1624072-1Quality management systemIssuedOct 9, 2024 → Oct 8, 2029

Scope coverage

IVDR Class B2

2 scopes

INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050104 - HELICOBACTER PYLORI
IVDR Class B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021004 - VASCULITIS
IVDR Class B

Documents

LanguagesEN