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Amøbe saltvann

by Oslo universitetssykehus HF Norway EUDAMED

Ref Not applicable

EMDN W0104050199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number7073097KOPPARROR01SKL0167 Basic UDI-DIDate4 Aug 2025RegisteredStatusActive

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
Amøbe dyrkningsmedium
Model / Reference
Not applicable
Primary DI / UDI-DI
07073097800795
Basic UDI-DI
7073097KOPPARROR01SKL0167
EMDN Code
W0104050199 Parasitology reagents - other
Device Class
Class A
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000028214

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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 3be1bb2d-eb31-4006-b78d-9cef443b03d8 61 fields · synced 22 Oct 2026