Skip to content

Mirasol™ Illuminator

by Terumo BCT, Inc.

Ref 11000Model Mirasol Illuminator, Mirasol™ Illuminator

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number5020583MirasolIlluminatWP Basic UDI-DI 05020583110007UDI-DIDate10 Sep 2026RegisteredStatusActive
European UnionCE/MDR Number5020583MirasolIlluminatWP Basic UDI-DI 05020583110007UDI-DIDate10 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
Mirasol Illuminator, 11000, Mirasol™ Illuminator
Primary DI / UDI-DI
05020583110007
Basic UDI-DI
5020583MirasolIlluminatWP, B-05020583110007
EMDN Code
Z12040202 Phototherapy equipment
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000001069
Authorised representative
Terumo BCT Europe N.V. BE-AR-000001030

Other devices from Terumo BCT, Inc..

See all devices from Terumo BCT, Inc.. →

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