Skip to content

Terumo

by Terumo Penpol Private Limited 86 variants

Ref PB-5RO356J0Y

Withdrawn Withdrawn in European Union.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

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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 NumberB-58904009335002 Basic UDI-DI 58904009335002UDI-DIDate25 May 2026RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device Name
Terumo Blood Bag
Model / Reference
PB-5RO356J0Y
Primary DI / UDI-DI
58904009335002
Basic UDI-DI
B-58904009335002
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

Other devices from Terumo Penpol Private Limited

See all devices from Terumo Penpol Private Limited →

Properties

  • 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