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MRX Red Free Protein S

by Nordic Biomarker AB Sweden EUDAMED

Ref K5009 EMDN W0103020612

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-27350060320219 Basic UDI-DIDate10 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Red Free Protein S
Model / Reference
K5009
Primary DI / UDI-DI
27350060320219, 27350060320790
Basic UDI-DI
B-27350060320219, B-27350060320790
EMDN Code
W0103020612 Free protein s antigen
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000022201

From the manufacturer

Manufacturer's product page: Red Free Protein S

Other devices from Nordic Biomarker AB

See all devices from Nordic Biomarker AB →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 8b0774d7-aba7-41f4-96c2-118a03076340 61 fields · synced 22 Oct 2026
  • EUDAMED 27350060320790|B-27350060320790 61 fields · synced 25 Oct 2026