Genome Diagnostics B.V.
NL-MF-000000453 · Netherlands · Utrecht
Genome Diagnostics B.V. is registered in the European database on medical devices as a manufacturer, with 77 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- KMRtrack® KMR014
- KMRtrack® KMR017
- KMRtrack® KMR028
- KMRtrack® KMR031
- KMRtrack® KMR034
- KMRtrack® KMR038
- KMRtrack® KMR043
- KMRtrack® KMR048
- KMRtrack® KMR049
- KMRtrack® KMR055
- NGSengine®
- NGSgo®-AmpX v3 HLA-A, B, C, DRB1, DRB3/4/5, DQB1, DQA1, DPB1, DPA1
Showing 12 of 77 declared devices.
Catalogue references include 4949940, 4949740, 4949840, 4949640, 7933862, 7971464, 8844342-14, 8844342-38, 8844342-43.
European nomenclature codes declared: W010699, W01030499, W02050192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 77 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GENOME DIAGNOSTICS B.V. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 4 |
| First licensed | 2017-07-10 |
Licence types: Test Kit (3), Device Family (1).
Licensed under: NGSENGINE, NGSGO-MX6-1 MULTIPLEX AMPLIFICATION KIT, NGSGO-AMPX V2 AMPLIFICATION KITS, GENDX NGSGO-MX11-3 MULTIPLEX HLA AMPLIFICATION.
North American profile: Canada only. Genome Diagnostics B.V. holds a Canadian licence but was not found in the U.S. register.