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Adellgene® Fragile X Screening 16 tests

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

Ref AD-FX-16Model Adellgene® Fragile X Screening

EMDN W0106010104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08437016942291 Basic UDI-DIDate8 Feb 2024RegisteredStatusActive

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

Model / Reference
Adellgene® Fragile X Screening, AD-FX-16
Primary DI / UDI-DI
08437016942291
Basic UDI-DI
B-08437016942291
EMDN Code
W0106010104 Fragile x syndrome
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

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

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Properties & raw data

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

Sources (1)

  • EUDAMED 7a3446e2-1026-4920-921f-ae96272f05ef 61 fields · synced 22 Oct 2026