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PLS Bags w/NaCl Spike

by Haemonetics S.A. EUDAMED

Active European Union

Ref 692AU-00Model Plasma Harness-out Sets

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081274701PLS00942 Basic UDI-DIDate8 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Plasma Harness-out Sets, 692AU-00
Primary DI / UDI-DI
10812747011433
Basic UDI-DI
081274701PLS00942
EMDN Code
B030101 Apheresis plasma collection devices
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000034549
Authorised representative
Haemonetics Italia s.r.l IT-AR-000021067

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Properties

  • 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