Blackhills Diagnostic Resources S.L.U.
ES-MF-000001091 · Spain · Zaragoza
Blackhills Diagnostic Resources S.L.U. is registered in the European database on medical devices as a manufacturer, with 73 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Adellgene® Fragile X, Genvinset® FIIFV multiplex, Genvinset® Factor II G20210A 24 test, Genvinset® HFE H63D, Genvinset® HFE S65C.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- Adellgene® Fragile X 25 tests
- Genvinset® FIIFV multiplex 48 test
- Genvinset® FIIFV multiplex 96 test
- Genvinset® Factor II G20210A 96 test
- Genvinset® HFE C282Y 96 tests
- Genvinset® HFE H63D 24 tests
- Genvinset® HFE S65C 48 tests
- Genvinset® HLA B51 48 test
- Genvinset® MTHFR A1298C 96 tests
- Genvinset® MTHFR multiplex 24 test
- Genvinset® PAI-1 4G/5G 48 tests
- Genvinset® PAI-1/FXIII multiplex 24 test
Showing 12 of 73 declared devices.
Catalogue references include AD-FMR1-25, GVS-B51-48, GVS-FII-96, GVS-FIIFV-48, GVS-MTH-M-24, GVS-PAI-48.
European nomenclature codes declared: W0106010401, W0106010499, W0106010116, W0103020299, W0106010105, W0106010104.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 73 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 73 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Blackhills Diagnostic Resources S.L.U. was not found in either the U.S. or the Canadian register.