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Leukocyte Reduction Filter for Blood

by Nanjing Shuangwei Biotechnology Co., Ltd. 5 variants

Ref FTS-PL110

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69523203FTSZQ Basic UDI-DI 06952320390900UDI-DIDate19 Jan 2026RegisteredStatusActive EUDAMED: not 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Leukocyte Reduction Filter for Blood
Model / Reference
FTS-PL110
Primary DI / UDI-DI
06952320390900
Basic UDI-DI
69523203FTSZQ
EMDN Code
B02010102 Bed-side platelets leukoreduction filters (with or without infusion controller)
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
CN-MF-000023311
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties

  • Sterile
  • CMR Substance

Other properties (11)

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