XVIVO Perfusion AB
SE-MF-000018108 · Sweden · Mölndal
XVIVO Perfusion AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: 1.9.
Among these devices, 3 are declared sterile, 3 active.
Devices declared under this manufacturer
- XVIVO Heart Assist Transport™
- XVIVO Lung Cannula Set™
- XVIVO Organ Chamber™
- XVIVO PGM Disposable Sensors™
- XVIVO Perfusion System (XPS™)
Catalogue references include 19020, 19022, 19033, 19040, 19420.
European nomenclature codes declared: C0399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | XVIVO PERFUSION AB (SE) · FDA 3007710603 |
| Devices in EUDAMED | 5 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 60.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | XVIVO PERFUSION AB |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2015-11-17 |
Licence types: Single Device (1).
Licensed under: XVIVO PERFUSION SYSTEM (XPS).
North American profile: Both markets. XVIVO Perfusion AB is registered in both the United States and Canada.