Genvinset® deltaF508 48 tests

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

Ref GVS-DF508-48Model Genvinset® deltaF508

EMDN W0106010101

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-08437016942895 Basic UDI-DI	Date30 Oct 2023Registered	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

Model / Reference: Genvinset® deltaF508, GVS-DF508-48

Primary DI / UDI-DI: 08437016942895
Basic UDI-DI: B-08437016942895
EMDN Code: W0106010101 Cystic fibrosis

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

Sterile
Microbial Substances
Reagent
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED b1aa9a9b-180c-4106-aaf2-a16cc5f55c1b 61 fields · synced 22 Oct 2026