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microINR EasyControl

by Iline Microsystems S.L. Spain EUDAMED

Ref EKA0005UUModel EKA0005UU

EMDN W0103020702

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436540291165 Basic UDI-DIDate11 Dec 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
microINR EasyControl (High)
microINR EasyControl (Low)
Model / Reference
EKA0005UU
Primary DI / UDI-DI
08436540291165, 08436540290083
Basic UDI-DI
B-08436540291165, B-08436540290083
EMDN Code
W0103020702 Control plasma for haemostasis
Device Class
Class IVD General
Market of Registration
Spain
Sweden

Manufacturer details

EUDAMED SRN
ES-MF-000013573

Other devices from Iline Microsystems, S.L.

See all devices from Iline Microsystems, S.L. →

Properties & raw data

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

Sources (2)

  • EUDAMED 8c227413-ee41-4b30-9aa3-7ff0ef99a51e 61 fields · synced 24 Oct 2026
  • EUDAMED 08436540290083|B-08436540290083 61 fields · synced 6 Oct 2026