EU Manufacturer
๐ฆ๐น Austria
Active
Eurolyser Diagnostica GmbH
SRN: AT-MF-000013746
ยท
Gewerbehofstrasse 8a, 5023 Salzburg, Austria
Basic UDI-DIs
26
Total Devices
26
On Market
26
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
15
Basic Information
- Address
- Gewerbehofstrasse 8a, 5023 Salzburg, Austria
- [email protected]
- Phone
- +43 662 432100
- Website
- www.eurolyser.com
Regulatory Overview
Regulation
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Eu Ivdd
24
Eu Ivdr
2
Classification
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Eu Ivd General
24
Eu Ivd Class A
2
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 15 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CRP control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| CRP test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| CRP with integrated capillary test kit (16 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| CRP with integrated capillary test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| CUBE-S Analyser (700/546) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Cystatin C (GFR) control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| Cystatin C (GFR) test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| D-Dimer control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| D-Dimer test kit (16 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| D-Dimer test kit (6 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| Ferritin control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| Ferritin test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| Ferritin test kit (16 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| HbA1c control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| HbA1c test kit (24 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| Lipoprotein (a) control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| Lipoprotein (a) test kit (16 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| PT (INR) control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| PT (INR) test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| Troponin I test kit (6 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| Troponin I control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| hsCRP control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| hsCRP test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |
| iFOB collector kit (32 pcs, incl. collection paper) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| iFOB control kit | EU IVDD | Eu Ivd General | On Market | 0 |
| iFOB test kit (32 tests) | EU IVDD | Eu Ivd General | On Market | 0 |