medPhoton GmbH

Certificate D4005200012

Supplemented

Valid until: Apr 13, 2027

Certificate D4005200012 is a valid Quality management system issued to medPhoton GmbH and registered in EUDAMED. Valid until April 13, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: D4005200012
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0483D4005200012

Validity

Issued: Jun 2, 2026
Valid from: Jun 2, 2026
Valid until: Apr 13, 2027

Manufacturer

Manufacturer: medPhoton GmbH
Manufacturer SRN: AT-MF-000002648
Manufacturer country: Austria

Notified body

Notified body
Notified body SRN: 0483
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

D4005200011RestrictedFeb 12, 2025 → Apr 13, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

Mobile ImagingRing System (IRm, Loop-X Mobile Imaging Robot)
Class IIb

Documents

LanguagesEN