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Adellgene® SCAs 16 tests

by Blackhills Diagnostic Resources S.L.U. Spain EUDAMED

Ref AD-SCA-16Model Adellgene® SCAs EMDN W0106010113

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437016942AD-SCA2A Basic UDI-DIDate31 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Adellgene® SCAs
Model / Reference
Adellgene® SCAs, AD-SCA-16
Primary DI / UDI-DI
08437016942437
Basic UDI-DI
8437016942AD-SCA2A
EMDN Code
W0106010113 Spinocerebellar ataxins type 1,2,3,6,7,8
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

Other devices from Blackhills Diagnostic Resources S.L.U.

See all devices from Blackhills Diagnostic Resources S.L.U. →

Properties & raw data

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

Sources (1)

  • EUDAMED 75b31e91-599d-4306-a04f-3e7825a93c40 61 fields · synced 22 Oct 2026