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MH Guide

by Molecular Health GmbH Germany EUDAMED

Ref 1000000128

EMDN W02050192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4260563550237VS Basic UDI-DIDate7 Dec 2021RegisteredStatusActive

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
1000000128
Primary DI / UDI-DI
04260563550312, 04260563550329, 04260563550275, 04260563550343
Basic UDI-DI
4260563550237VS
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000012861

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (4)

  • EUDAMED e930b1db-304e-43b0-a9ed-259e5c5bc277 61 fields · synced 22 Oct 2026
  • EUDAMED 04260563550329|4260563550237VS 61 fields · synced 17 May 2026
  • EUDAMED 04260563550275|4260563550237VS 61 fields · synced 19 May 2026
  • EUDAMED 04260563550343|4260563550237VS 61 fields · synced 19 May 2026