Skip to content

Delft One

by Delft Imaging Systems B.V. EUDAMED

Active European Union EUDAMED: not on the EU market

Ref DelftOne

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426240072DelftOneVU Basic UDI-DIDate17 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Delft One
Model / Reference
DelftOne
Primary DI / UDI-DI
42624007200490
Basic UDI-DI
426240072DelftOneVU
EMDN Code
Z11039016 Mobile radiographic units
Device Class
Class IIb
Medical Purpose
The DelftOne is a portable X-ray system that can be deployed in almost any venue, room or even under a tent. Local radiation safety rules need to be followed to obtain high-quality images with the least amount of radiation (ALARA principle). Because of its nature, there is no ‘standard’ setup for the DelftOne the setup always depends on the venue used, amount of space, patient flow, etc. Some considerations for a correct use are: • Patient flow; Where do patients enter/exit the room? • X-ray beam direction; Where does the primary beam point to? This might be a trade-off with the patient flow. • Radiographer area; What is a safe distance for the radiographer? Is additional lead shielding available? • Imaging distance; What is the maximum distance between the X-ray and detector stand? The distance should be at least 120 cm.

Manufacturer details

EUDAMED SRN
NL-PR-000033500

Other devices from Delft Imaging Systems B.V.

Properties

Other properties (1)

  • Sterile: No