Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

DeviceProduct codeClassRoleSource
System, Perfusion, KidneyKDN2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 20, 2022K211333KIDNEY ASSIST-transportKDNSubstantially EquivalentXvivo Perfusion ABaccessdata.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.