EU Manufacturer
🇭🇺 Hungary
Active
Omixon Biocomputing Ltd.
SRN: HU-MF-000003018
·
Kaposvár utca 14-18., H-1117 Budapest, Hungary
Basic UDI-DIs
22
Total Devices
24
On Market
21
Off Market
3
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
15
Basic Information
- Address
- Kaposvár utca 14-18., H-1117 Budapest, Hungary
- [email protected]
- Website
- https://www.omixon.com/
Regulatory Overview
Regulation
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Eu Ivdd
21
Eu Ivdr
1
Classification
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Eu Ivd Annex 2 List B
17
Eu Ivd General
4
Eu Ivd Class C
1
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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Market Presence
Devices from this manufacturer are available in 15 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇬🇷 Greece
🇪🇸 Spain
🇫🇷 France
🇭🇺 Hungary
🇮🇹 Italy
🇷🇴 Romania
🇸🇮 Slovenia
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AzureSeq 4 CE qPCR Kit for 200 Reactions | EU IVDD | Eu Ivd General | Off Market | 0 |
| AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions | EU IVDD | Eu Ivd General | Off Market | 0 |
| AzureSeq CE qPCR Kit SARS-CoV-2 for 400 Reactions | EU IVDD | Eu Ivd General | Off Market | 0 |
| Holotype HLA 24/11 - Configuration A1 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/11 - Configuration A2 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/11 - Configuration A3 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/11 - Configuration A4 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/7 - Configuration A1 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/7 - Configuration A2 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/7 - Configuration A3 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 24/7 - Configuration A4 & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/11 - Configuration A & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/11 - Configuration B & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/11 - Configuration C & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/5 - Configuration A & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/5 - Configuration B & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/5 - Configuration C & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/7 - Configuration B & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/7 - Configuration C & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Holotype HLA 96/7 – Configuration A & CE v2 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| NanoTYPE 24/11 CE | EU IVDR | Eu Ivd Class C | On Market | 0 |
| NanoTYPE 4x96/11 CE | EU IVDR | Eu Ivd Class C | On Market | 0 |
| NanoTYPE 96/11 CE | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Omixon HLA TWIN | EU IVDD | Eu Ivd General | On Market | 0 |