DIESSE Diagnostica Senese S.p.A
IT-MF-000013311 · Italy · Milan
DIESSE Diagnostica Senese S.p.A is registered in the European database on medical devices as a manufacturer, with 100 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: CHORUSCHA, CHORUSCLPM, CHORUSHSG, CHORUSIAA, CHORUSIAG.
Among these devices, 2 are declared sterile.
Devices declared under this manufacturer
- CHORUS CARDIOLIPIN-M
- CHORUS CHLAMYDOPHILA PNEUMONIAE IgA
- CHORUS CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS
- CHORUS CLIA MEASLES IgG
- CHORUS ELASTASE COPROCOLLECT
- CHORUS HERPES SIMPLEX 1+2 IgG
- CHORUS INFLUENZA A IgA
- CHORUS INFLUENZA A IgG
- CHORUS MPO
- CHORUS WEST NILE IgM
- CHORUS tTg-G
- CUBE 30 TOUCH
Showing 12 of 100 declared devices.
Catalogue references include 10602, 81020, 81190, 81192/12, 81252, 86048.
European nomenclature codes declared: W0105040604, W0102100501, W0102100402, W0102100601, W0102100503, W0102100101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DIESSE DIAGNOSTICA SENESE S.P.A (IT) · FDA 9615056 |
| Devices in EUDAMED | 100 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 100 |
|---|---|
| Found in the U.S. device database | 15 |
| Share | 15.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DIESSE DIAGNOSTICA SENESE S.P.A. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2005-12-19 |
Licence types: Device Family (2), Test Kit (1), System (1).
Licensed under: PLATELIA MUMPS IGG, VES-MATIC AUTOMATED ESR INSTRUMENT, ESR CONTROL, CHORUS TRIO.
North American profile: Both markets. DIESSE Diagnostica Senese S.p.A is registered in both the United States and Canada.