Data / Medical devices / Netherlands / Xvivo BV
Xvivo BV: FDA-registered device maker in Groningen, Netherlands, 1 510(k) clearance
Xvivo BV is registered with the FDA (registration 3021739803) in Groningen, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021739803
- Address
- Bornholmstraat 84, Groningen, Netherlands, 9723 AZ
- Owner or operator
- XVIVO Perfusion AB (10029831)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 7, 2022
- Registered through
- 2026
- Brand names listed
- Kidney Assist Transport, Kidney Assist Transport Perfusion Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Perfusion, Kidney | KDN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2022 | K211333 | KIDNEY ASSIST-transport | KDN | Substantially Equivalent | Xvivo Perfusion AB | accessdata.fda.gov |
Compare with other makers
Updated January 20, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.