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Strep A test kit

by Salofa Oy Finland EUDAMED

Ref 75-75STREPA-xx

EMDN W0105090103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FIMF168237575STREPAxxGG Basic UDI-DIDate26 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
Strep A test kit
Model / Reference
75-75STREPA-xx
Primary DI / UDI-DI
D-FIMF168237575STREPAxxGG
Basic UDI-DI
B-FIMF168237575STREPAxxGG
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
FI-MF-000016823

Other devices from Salofa Oy

See all devices from Salofa Oy →

Properties & raw data

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

Sources (1)

  • EUDAMED 5cd3d035-57bc-4916-90ba-655d33c03c22 61 fields · synced 22 Oct 2026