Adellgene® Myotonic Dystrophy Screening 16 tests

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

Ref AD-MD-16Model Adellgene® Myotonic Dystrophy Screening

EMDN W0106010199

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-08437016942338 Basic UDI-DI	Date8 Feb 2024Registered	StatusActive

Coverage

1 jurisdiction

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: Adellgene® Myotonic Dystrophy Screening 16 tests
Model / Reference: Adellgene® Myotonic Dystrophy Screening, AD-MD-16

Primary DI / UDI-DI: 08437016942338
Basic UDI-DI: B-08437016942338
EMDN Code: W0106010199 Monogenetic disorders tests - other

Device Class: Class IVD General
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 (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED be2a4f46-8f44-4ae5-9505-b70feb15b9a5 61 fields · synced 22 Oct 2026