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HLA B5701 Strip

by Operon, S.A. Spain EUDAMED

Ref 3.155.048.53.000Model 3.155.XXX.YY.ZZZ EMDN W0106010401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number84295773155WV Basic UDI-DIDate1 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
3.155.XXX.YY.ZZZ, 3.155.048.53.000
Primary DI / UDI-DI
08429577002910
Basic UDI-DI
84295773155WV
EMDN Code
W0106010401 Hla-typing
Device Class
Class C
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
  • Companion Diagnostics
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08429577002910|84295773155WV 61 fields · synced 24 Oct 2026