Omixon Biocomputing Ltd.
HU-MF-000003018 · Hungary · Budapest
Omixon Biocomputing Ltd. is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: AzureSeq-400 CE, H26, H32.1, H58, H60.
Devices declared under this manufacturer
- AzureSeq 4 CE qPCR Kit for 200 Reactions
- AzureSeq CE qPCR Kit SARS-CoV-2 for 400 Reactions
- Holotype HLA 24/11 - Configuration A2 & CE v2
- Holotype HLA 24/11 - Configuration A3 & CE v2
- Holotype HLA 24/11 - Configuration A4 & CE v2
- Holotype HLA 24/7 - Configuration A2 & CE v2
- Holotype HLA 24/7 - Configuration A3 & CE v2
- Holotype HLA 24/7 - Configuration A4 & CE v2
- Holotype HLA 96/11 - Configuration A & CE v2
- Holotype HLA 96/11 - Configuration B & CE v2
- Holotype HLA 96/5 - Configuration C & CE v2
- Holotype HLA 96/7 - Configuration C & CE v2
Showing 12 of 27 declared devices.
Catalogue references include AzureSeq-400 CE, H32.1, H58, H60, H64, H68.
European nomenclature codes declared: W01030499, W0105040519, W02050192, W010699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 27 |
| Country of registration | Hungary |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| 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. Omixon Biocomputing Ltd. was not found in either the U.S. or the Canadian register.