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MDX Hemaline 500S

by MDX Netherlands Diagnostics inc Philippines EUDAMED

Ref MDX Hemaline 500S EMDN W02020699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number480654136HEMAANAFH Basic UDI-DIDate20 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hematology Analyzer
Model / Reference
MDX Hemaline 500S
Primary DI / UDI-DI
04806541360001
Basic UDI-DI
480654136HEMAANAFH
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
PH-MF-000050095
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from MDX Netherlands Diagnostics inc

Properties & raw data

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

Sources (1)

  • EUDAMED ef34a66f-ee8f-4f44-89bf-810fa8e5048a 61 fields · synced 22 Oct 2026