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3Dnet

by Biotronics 3D Limited United Kingdom EUDAMED

Ref 506075752MEDICALIMAGINGLF EMDN Z110603

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075752MEDICALIMAGINGLF Basic UDI-DIDate4 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
3Dnet
Model / Reference
506075752MEDICALIMAGINGLF
Primary DI / UDI-DI
05060757520003
Basic UDI-DI
506075752MEDICALIMAGINGLF
Direct Marketing DI
05060757520003
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
UK-MF-000051724
Authorised representative
Skyer Medical Imaging S.R.L. RO-AR-000049393

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ebbff86b-55e4-49ec-b10d-4cb1e88905b4 61 fields · synced 23 Oct 2026