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5697278

by Lumitex Medical Devices, Inc. EUDAMED

Active European Union

Ref 5697278Model BiliSoft 2.0 PT Systems, Large Pad, Brazilian, CE Plug

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00812432022372 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  • Withdrawn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, Brazilian, CE Plug, 5697278
Primary DI / UDI-DI
00812432022372
Basic UDI-DI
B-00812432022372
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIa
Market of Registration
Portugal

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