XVIVO PERFUSION AB

FDA Device Registration & Listing · Molndal Vastra Gotaland, SE · Registration 3007710603

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007710603
FEI Number
3007710603
Entity Name
XVIVO PERFUSION AB
City/State/Country
Molndal Vastra Gotaland, SE
Establishment Address
Entreprenorsstraket 10, Molndal Vastra Gotaland 43153, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
XVIVO Perfusion AB (Owner Number: 10029831)
Owner / Operator Contact Address
Entreprenorsstraket 10, Mölndal, SE-O 43153, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P180014

All Registered Proprietary Names

Perfadex Plus XPS Disposable Lung Circuit XVIVO Organ Chamber XVIVO PGM STEEN Solution XVIVO Disposable Kit XPS XVIVO Lung Cannula 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 2019-11-23
PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs Unknown Class 3 N/A 2019-11-23

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
3021739803 XVIVO BV Groningen, NL
3009736925 XVIVO PERFUSION, INC. Golden, CO, US

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 3007710603. Last updated year: 2026. Please use registration number 3007710603 when referencing this establishment in official correspondence.
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