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Diluent pH-7

by Labex Reagens AB Sweden EUDAMED

Ref TV002

EMDN W01030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number73501450010021002SX Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TV002
Primary DI / UDI-DI
07350145000322
Basic UDI-DI
73501450010021002SX
Direct Marketing DI
07350145000322
EMDN Code
W01030399 Immunohaematology (blood grouping) tests - other
Device Class
Class A
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
SE-MF-000048594

Other devices from Labex Reagens AB

See all devices from Labex Reagens AB →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED dab1ae0a-cecb-4662-b7dd-bcebb442a011 61 fields · synced 22 Oct 2026