ARCHImedline GmbH

Certificate IQMS/00010/0v001

Rev. v001Issued

Valid until: Jul 8, 2031

Certificate IQMS/00010/0v001 is a valid Quality management system issued to ARCHImedline GmbH and registered in EUDAMED. Valid until July 8, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IQMS/00010/0v001
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/00010/0v001v001

Validity

Issued: Jul 9, 2026
Valid from: Jul 9, 2026
Valid until: Jul 8, 2031

Manufacturer

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
Manufacturer country: Austria

Notified body

Notified body
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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B2

2 scopes

IVR 0602
IVDR Class B
Lyso Triplex LC-MS/MS Kit
IVDR Class B

Documents

LanguagesEN