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5514310

by Lumitex Medical Devices, Inc. EUDAMED

Active European Union

Ref 5514310Model BiliSoft 2.0 PT Systems, Small Pad, Romanian, CE Plug

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00812432022051 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD 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

Model / Reference
BiliSoft 2.0 PT Systems, Small Pad, Romanian, CE Plug, 5514310
Primary DI / UDI-DI
00812432022051
Basic UDI-DI
B-00812432022051
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
US-MF-000030520
Authorised representative
MDSS GmbH DE-AR-000005430

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See all devices from Lumitex Medical Devices, Inc. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No