ElitechGroup S.p.A.
IT-MF-000005919 · Italy · Torino
ElitechGroup S.p.A. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- CMV - ELITe Positive Control
- Candida auris - ELITe Positive Control
- Candida auris ELITe MGB® Kit
- EBV - ELITe Positive Control
- EBV ELITe MGB® Kit
- EBV ELITe Standard
- GI Viral PLUS ELITe MGB® Kit
- HSV1 - ELITe Positive Control
- HSV1 ELITe MGB® Kit
- HSV2 - ELITe Positive Control
- HSV2 ELITe MGB® Kit
- HSV2 ELITe Standard
Showing 12 of 19 declared devices.
Catalogue references include CTR015PLD, CTR035PLD, CTR203ING, RTS031PLD, RTS032PLD, RTS035PLD.
European nomenclature codes declared: W0105080808, W0105080908, W0105040311, W0105040904, W0105070504, W0105060404.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELITechGroup S.p.A. (IT) · FDA 3011461582 |
| Devices in EUDAMED | 19 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 19 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ELITECHGROUP S.P.A |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2016-10-25 |
Licence types: Test Kit (9), System (2).
Licensed under: ADENOVIRUS ELITE MGB KIT, BKV ELITE MGB KIT, PARVOVIRUS B19 ELITE MGB KIT, VZV ELITE MGB KIT, HHV6 ELITE MGB KIT, HHV7 ELITE MGB KIT.
North American profile: Both markets. ElitechGroup S.p.A. is registered in both the United States and Canada.