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ThEA RapiDx

by RAM THz Solutions GmbH Germany EUDAMED

Ref 4000RapiDxModel RapiDx

EMDN W0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DEMF0000239784000RD7R 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

Device Name
ThEA Rapid Diagnostics
Model / Reference
RapiDx, 4000RapiDx
Primary DI / UDI-DI
D-DEMF0000239784000RD7R
Basic UDI-DI
B-DEMF0000239784000RD7R
EMDN Code
W0299 IVD instruments - other
Device Class
Class IVD General
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
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 52e78561-ceb0-4b53-b119-1ec183a667a0 61 fields · synced 22 Oct 2026