EXAMION GmbH

Certificate C571689

Rev. 0Issued

Valid until: Jul 9, 2030

Certificate C571689 is a valid Quality management system issued to EXAMION GmbH and registered in EUDAMED. Valid until July 9, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C571689
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5716890

Validity

Issued: Jul 9, 2025
Valid from: Jul 9, 2025
Valid until: Jul 9, 2030

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

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: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

The X-AQS software is intended for examination and investigation of the anatomy or of a physiological or pathological process or state based on medical image data, with the goal of a medical diagnosis of diseases or injuries. X-AQS provides capabilities for X-ray image acquisition as well as functionalities of a picture archiving and communication system for management of further medical image data.
Class IIb
X-AQS Brand name: - BAROWI-Vision AQS - MEBITECH AQS
Class IIb

Documents

LanguagesEN