MACHEREY-NAGEL GmbH & Co. KG

Certificate HX 1038121-1

Rev. Rev. 0Issued

Valid until: May 15, 2028

Certificate HX 1038121-1 is a valid Quality management system issued to MACHEREY-NAGEL GmbH & Co. KG and registered in EUDAMED. Valid until May 15, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1038121-1
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 1038121-1Rev. 0

Validity

Issued: May 16, 2023
Valid from: May 16, 2023
Valid until: May 15, 2028

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: Yes
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 B3IVDR Class C1

4 scopes

IVR 608: W01010602 URINE TESTING (CC) - RT & POC
IVDR Class B
Products of class B, for near-patient testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC W01010699 CLIN. CHEM. RT & POC - OTHER
IVDR Class B
Products of class B, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC
IVDR Class B
Products of class C, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC
IVDR Class C

Documents

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