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Cellex Clxusa

by Therakos, Inc. EUDAMEDGUDID

Active European Union and United States

Ref CLXECPModel THERAKOS CELLEX PROCEDURAL KIT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705030_CELLEX_EPP_Acc_3P Basic UDI-DIDate25 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20705030200003 UDI-DIDate29 Aug 2014ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
Therakos Cellex Photopheresis System Procedural Kit EUDAMED
Cellex GUDID
Generic Name
Photopheresis system blood set
Model / Ref / Catalog
THERAKOS CELLEX PROCEDURAL KIT EUDAMED
CLXECP EUDAMED
CLXUSA GUDID
Primary DI / UDI-DI
20705030200003
Basic UDI-DI
0705030_CELLEX_EPP_Acc_3P
FDA Product Code
LNR
EMDN Code
B030204 Extracorporeal photochemotherapy or photopheresis devices and kits
GMDN Term
Photopheresis system blood set
Device Class
Class IIa EUDAMED
Class III GUDID
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
THERAKOS CELLEX PROCEDURAL KIT
CLXECP
GUDID
CLXUSA
Device ClassEUDAMED
Class IIa
GUDID
Class III
Contains LatexEUDAMED
No
GUDID
Yes

Related devices

Category: Photopheresis system blood set

Similar devices

Also classified as Photopheresis system blood set.

Other devices from Therakos, Inc.

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Properties

  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No