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Spectra Optia™ Exchange Set

by Terumo BCT, Ltd. XI EUDAMED

Ref 10226Model Spectra Optia Exchange Set

EMDN B030199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5054638OptiaExchMF Basic UDI-DIDate12 Feb 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Spectra Optia Exchange Set, 10226
Primary DI / UDI-DI
05054638102266
Basic UDI-DI
5054638OptiaExchMF
EMDN Code
B030199 Apheresis collection devices - other
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
XI-MF-000004232

Other devices from Terumo BCT, Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
  • Endocrine Disruptor
Other properties (10)
  • 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

Sources (1)

  • EUDAMED ad3df5e2-cefe-48b8-8208-08ecf2bdea1f 61 fields · synced 23 Oct 2026