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Terumo

by Terumo Penpol Private Limited India EUDAMED

Ref PB-5RO456J0Y

EMDN B0101020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-58904009335033 Basic UDI-DIDate28 May 2026RegisteredStatusActive

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
Terumo Blood Bag
Model / Reference
PB-5RO456J0Y
Primary DI / UDI-DI
58904009335033
Basic UDI-DI
B-58904009335033
EMDN Code
B0101020102 Donor blood collection quintuple bags, with filters and kits
Device Class
Class III

Manufacturer details

EUDAMED SRN
IN-MF-000001071
Authorised representative
Terumo BCT Europe N.V. BE-AR-000001030

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Incorporates Medicinal Product
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 00273406-98b8-4320-a2f9-ffddbf30b1bc 61 fields · synced 22 Oct 2026