nal von minden GmbH

Certificate HX 1034230-1

Rev. Rev. 0Issued

Valid until: Feb 6, 2029

Certificate HX 1034230-1 is a valid Quality management system issued to nal von minden GmbH and registered in EUDAMED. Valid until February 6, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1034230-1
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: 0197HX 1034230-1Rev. 0

Validity

Issued: Feb 7, 2024
Valid from: Feb 7, 2024
Valid until: Feb 6, 2029

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: 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 B1

1 scope

Class B, near-patient testing IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050901 - BACTERIOLOGY - RT & POC
IVDR Class B

Documents

LanguagesEN