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Bilitron Sky 2006

by Fanem Medical Devices India Private Limited

Ref FANEM-CTL-2006Model Bilitron Sky 2006

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD, CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number8908025930BS20064B Basic UDI-DI 08908025930000UDI-DIDate7 Feb 2025RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDR Number8908025930BS20064B Basic UDI-DI 08908025930000UDI-DIDate7 Feb 2025RegisteredStatusWithdrawn No longer placed on the EU market

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Single Surface Phototherapy Unit
Model / Reference
Bilitron Sky 2006, FANEM-CTL-2006
Primary DI / UDI-DI
08908025930000
Basic UDI-DI
8908025930BS20064B, B-08908025930000
EMDN Code
Z12080401 Paediatric phototherapy equipment
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
IN-MF-000039532
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No