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SmartEIA ENA profile plus

by TestLine Clinical Diagnostics s.r.o. Czechia EUDAMED

Ref SK-ENAp12 EMDN W0102100102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08595635307591 Basic UDI-DIDate24 Sep 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  • Withdrawn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 25 Oct 2026

Device Name
SmartEIA ENA profile plus
Model / Reference
SK-ENAp12
Primary DI / UDI-DI
08595635307591
Basic UDI-DI
B-08595635307591
EMDN Code
W0102100102 Ena screening
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001803

Other devices from TestLine Clinical Diagnostics s.r.o.

See all devices from TestLine Clinical Diagnostics s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08595635307591|B-08595635307591 61 fields · synced 25 Oct 2026