SSI Diagnostica A/S
DK-MF-000023933 · Denmark · Hillerød
SSI Diagnostica A/S is registered in the European database on medical devices as a manufacturer, with 84 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Chrom MRSA agarplade
- Chrom StrepB agarplade
- Chrom StrepB/StaphA agarplade
- Chrom UTI/CN 5% Blodagarplade
- Decarboxylase m. ornithin
- Ekstraktbouillon kontrol
- Ekstraktbouillon m. sakkarose
- Ekstraktbouillon m.arabinose
- Gelatine
- Löwenstein Jensen BCG
- Oksebouillon (filtreret)
- PPLO U 10 C m. urinstof
Showing 12 of 84 declared devices.
Catalogue references include 1038, 1111, 1129, 213437, 213438, 3715.
European nomenclature codes declared: W0104010206, W0104010402, W0104010404, W01021699, W0104010407, W0201020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SSI Diagnostica A/S (DK) · FDA 9611882 |
| Devices in EUDAMED | 84 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 79 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SSI DIAGNOSTICA A/S |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2026-07-17 |
Licence types: Test Kit (1).
Licensed under: IMMUVIEW L. PNEUMOPHILA AND L. LONGBEACHAE URI.
North American profile: Both markets. SSI Diagnostica A/S is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V13 133113 0001 | issued | 2031-07-07 |