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Hemoglobin A2 elevated control

by Seleo S.r.l. Italy EUDAMED

Ref HC-111EL

EMDN W0103010504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HC-111ELTP Basic UDI-DIDate18 Apr 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 22 Oct 2026

Device Name
Hemoglobin A2 elevated control
Model / Reference
HC-111EL
Primary DI / UDI-DI
D-HC-111ELTP
Basic UDI-DI
B-HC-111ELTP
EMDN Code
W0103010504 Haemoglobin controls
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000045668

Other devices from Seleo S.r.l.

See all devices from Seleo S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6e7311ef-df98-4d4e-8fdc-12802cec9ef2 61 fields · synced 22 Oct 2026