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Pak Lx

by Immucor GTI Diagnostics, Inc

Ref PLX

Pak Lx (PLX) is a Class C device made by Immucor GTI Diagnostics, Inc, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08500795050B9K), active as of 8 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08500795050B9K Basic UDI-DI 10850079505039UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
PLX
Primary DI / UDI-DI
10850079505039
Basic UDI-DI
08500795050B9K
Direct marketing DI
10850079505039
EMDN code
W0103010605 Platelets
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000020921
Authorised representative
IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083

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Other devices filed under PLATELETS.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)