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2-ME Roztwór do różnicowania przeciwciał klasy IgM i IgG

by Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach Poland EUDAMED

Ref 918

EMDN W0103030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5904365620MEH4 Basic UDI-DIDate24 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
2-ME solution for the differrentiation of IgM and IgG antibodies
Model / Reference
918
Primary DI / UDI-DI
05904365620321
Basic UDI-DI
5904365620MEH4
Direct Marketing DI
05904365620321
EMDN Code
W0103030399 Antibody detection (immunohaematology) - other
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000037642

Other devices from Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

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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 ac830155-c3c4-4798-9376-486b43dbec34 61 fields · synced 22 Oct 2026