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XVIVO PERFUSION, INC.

Sweden · Mölndal

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 2Class III 1

plus 5 registration records and 4 510(k), 13 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class III 2IIa 5IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 4 510(k), 13 PMA, 1 excluded

Brazil3 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: XVIVO PERFUSION AB · XVIVO PERFUSION, INC.

FDA 510(k) clearances by year

12010 · K091989

12018 · K170826

12022 · K211333

12026 · K261644

FDA listed device types

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs 1System/Device, Pharmacy Compounding 1System, Perfusion, Kidney 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261644	Perfadex Plus	2026-07-23
US	K211333	KIDNEY ASSIST-transport	2022-01-20
US	K170826	Perfadex Plus	2018-06-22
BR	80102519137	XVIVO Organ Chamber	Class II
BR	80102519136	SISTEMA DE PERFUSÃO XVIVO (XPS)	Class II
BR	80102519138	XVIVO Lung Cannula Set	Class II
CA	86867	VIVOLINE LS 1	Class II

XVIVO PERFUSION, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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