iRT Systems GmbH

Certificate 1000169828

Rev. 01Issued

Valid until: Oct 10, 2028

Certificate 1000169828 is a valid Quality management system issued to iRT Systems GmbH and registered in EUDAMED. Valid until October 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000169828
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100016982801

Validity

Issued: Apr 3, 2024
Valid from: Apr 3, 2024
Valid until: Oct 10, 2028

Manufacturer

Manufacturer: iRT Systems GmbH
Manufacturer SRN: DE-MF-000013778
Manufacturer country: Germany

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

Covered devices

IQM Integral Quality MonitorClass IIb
++B505IQMQU

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

MDA 0301 - Active non-implantable devices utilising ionizing radiation
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN