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Careblue

by Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti. Türkiye EUDAMED

Ref CAREBLUEModel Led Phototherapy Device

EMDN Z12080401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-869931091PT5J Basic UDI-DIDate9 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Led Phototherapy Device
Model / Reference
Led Phototherapy Device, CAREBLUE
Primary DI / UDI-DI
D-869931091PT5J
Basic UDI-DI
B-869931091PT5J
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000019054

Other devices from Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ac373a20-a6c8-43d2-bf92-a5fe41e55127 61 fields · synced 22 Oct 2026