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2108747-001

by Lumitex Medical Devices, Inc. EUDAMED

Active European Union

Ref 2108747-001Model BiliSoft 2.0 PT Systems, Large Pad, Finnish, CE Plug

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00812432021856 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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, Large Pad, Finnish, CE Plug, 2108747-001
Primary DI / UDI-DI
00812432021856
Basic UDI-DI
B-00812432021856
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIa
Market of Registration
Finland

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