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ImmuView

by SSI Diagnostica A/S Denmark EUDAMED

Ref 98748

EMDN W01021699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ImmuView_PutMK Basic UDI-DIDate15 May 2025RegisteredStatusActive

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 24 Oct 2026

Device Name
ImmuView S. pneumoniae Antigen Test
Model / Reference
98748
Primary DI / UDI-DI
D-ImmuView_PutMK
Basic UDI-DI
B-ImmuView_PutMK
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000023933

Other devices from SSI Diagnostica A/S

See all devices from SSI Diagnostica A/S →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4c42a250-ab04-4881-80cf-d6f1fcf8d1df 61 fields · synced 24 Oct 2026