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Adellgene® Myotonic Dystrophy Confirmatory 16 tests

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

Ref AD-MD-C-16Model Adellgene® Myotonic Dystrophy Confirmatory

EMDN W0106010199

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Adellgene® Myotonic Dystrophy Confirmatory
Model / Reference
Adellgene® Myotonic Dystrophy Confirmatory, AD-MD-C-16
Primary DI / UDI-DI
08437016942345
Basic UDI-DI
8437016942AD-MDCZG
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001091

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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 04597239-7472-418e-9651-62339436b8f9 61 fields · synced 22 Oct 2026