EU Manufacturer
🇫🇮 Finland
Active
Uniogen Oy
SRN: FI-MF-000032341
·
Tykistökatu 4, 20520 Turku, Finland
Basic UDI-DIs
25
Total Devices
26
On Market
26
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Tykistökatu 4, 20520 Turku, Finland
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
24
Eu Ivdr
1
Classification
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Eu Ivd General
24
Eu Ivd Class A
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| GenomEra C. difficile Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra C. difficile Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra CDX Software | EU IVDR | Eu Ivd Class A | On Market | 0 |
| GenomEra CDX System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| GenomEra GBS Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra GBS Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra HSV 1/2, VZV + EV Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra HSV 1/2, VZV + EV Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra MRSA/SA AC Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra MRSA/SA AC Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra MRSA/SA Multi Swab Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra Norovirus Assay kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra Norovirus Assay kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra S. pneumoniae Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra S. pneumoniae Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2 2.0 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2 2.0 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra SARS-CoV-2, Flu A/B + RSV Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GenomEra® C. difficile Assay Kit | EU IVDD | Eu Ivd General | On Market | 0 |