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INRstar

by inVita intelligence Care Solutions Limited United Kingdom EUDAMED

Ref L103020101001Model V5

EMDN W0202020192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-L103020101001BF Basic UDI-DIDate20 May 2026RegisteredStatusActive

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

Model / Reference
V5, L103020101001
Primary DI / UDI-DI
D-L103020101001BF
Basic UDI-DI
B-L103020101001BF
EMDN Code
W0202020192 Coagulometers - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000004565
Authorised representative
Amstermed UK Ltd XI-AR-000023135

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 32cc9a15-169d-4e10-804c-fdb6c6c88e20 61 fields · synced 24 Oct 2026