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Mirasol™ Plasma Disposable Kit

by Terumo BCT, Inc.

Ref 10390Model Mirasol™ Plasma Disposable Kit

Active European Union

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05020583103900 Basic UDI-DI 05020583103900UDI-DIDate26 Feb 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
Mirasol™ Plasma Disposable Kit, 10390
Primary DI / UDI-DI
05020583103900
Basic UDI-DI
B-05020583103900
EMDN Code
Z12040202 Phototherapy equipment
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

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

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Properties

  • Sterile
  • Animal Tissues

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No