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ThEA SARS-CoV-2 plugin

by RAM THz Solutions GmbH Germany EUDAMED

Ref 4310SC2 PluginModel SARS-CoV-2 plugin

EMDN W02079092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DEMF0000239784310SC92 Basic UDI-DIDate8 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SARS-CoV-2 plugin, 4310SC2 Plugin
Primary DI / UDI-DI
D-DEMF0000239784310SC92
Basic UDI-DI
B-DEMF0000239784310SC92
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000023978

Other devices from RAM THz Solutions GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 8762bb3b-ef05-4c77-a9c2-e878aa1bb9c3 61 fields · synced 22 Oct 2026