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ThromboSrip

by Operon, S.A. Spain EUDAMED

Ref 3.117.XXX.YY.ZZZ EMDN W0106010115

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-84295773117WMFQ Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
ThromboStrip
Model / Reference
3.117.XXX.YY.ZZZ
Primary DI / UDI-DI
D-84295773117WMFQ
Basic UDI-DI
B-84295773117WMFQ
EMDN Code
W0106010115 Combined factor ii / factor v leiden
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000004790

Other devices from Operon, S.A.

See all devices from Operon, S.A. →

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 (1)

  • EUDAMED 445f3b22-7713-4be1-9ea9-9b6f16777e5b 61 fields · synced 23 Oct 2026