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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

Visage Imaging GmbH

Certificate HZ 1838019-1

Rev. Rev. 1Supplemented

Valid until: Jul 15, 2030

Overview

Certificate number: HZ 1838019-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1838019-1Rev. 1

Validity

Issued: Jul 16, 2025
Valid from: Jul 16, 2025
Valid until: Jul 15, 2030

Manufacturer

Manufacturer: Visage Imaging GmbH
Manufacturer SRN: DE-MF-000006561
Manufacturer country: Germany

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: No
Initial registration: No
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1838019-1Quality management systemIssuedJul 16, 2025 → Jul 15, 2030

Scope coverage

Class IIb1

1 scope

Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
Class IIb

Documents

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