Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021739803

FEI Number

3021739803

Entity Name

XVIVO BV

City/State/Country

Groningen, NL

Establishment Address

Bornholmstraat 84, Groningen 9723 AZ, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

XVIVO Perfusion AB (Owner Number: 10029831)

Owner / Operator Contact Address

Entreprenorsstraket 10, Mölndal, SE-O 43153, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211333

PMA Number

N/A

All Registered Proprietary Names

Kidney Assist Transport Kidney Assist Transport Perfusion Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2022-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

Sara Garton Business: XVIVO Perfusion INC Email: sara.garton@xvivogroup.com Phone: (720) 9007298

Related Public Records

Same Entity

XVIVO Perfusion AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3028907862	XVIVO PERFUSION, INC.	Aurora, CO, US
3009736925	XVIVO PERFUSION, INC.	Golden, CO, US
3007710603	XVIVO PERFUSION AB	Molndal Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021739803. Last updated year: 2026. Please use registration number 3021739803 when referencing this establishment in official correspondence.