XVIVO B.V.
NL-MF-000018307 · Netherlands · Groningen
XVIVO B.V. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 3 |
Among these devices, 4 are declared sterile, 3 active, 3 with a measuring function.
Devices declared under this manufacturer
- Kidney Assist Transport™
- Kidney Assist Transport™ Perfusion Set
- Kidney Assist™
- Kidney Assist™ Perfusion Set
- Liver Assist™
- Liver Assist™ Perfusion Set
- Liver Assist™ Perfusion Set - Single
Catalogue references include 11.101, 11.401, 13.401, 21.101, 21.401, 23.101.
European nomenclature codes declared: C0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 28.6 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | XVIVO B.V. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2025-04-09 |
Licence types: System (3).
Licensed under: KIDNEY ASSIST, LIVER ASSIST, KIDNEY ASSIST TRANSPORT.
North American profile: Canada only. XVIVO B.V. holds a Canadian licence but was not found in the U.S. register.