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ORGAN RECOVERY SYSTEMS, INC.

USA · Itasca

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 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

2listed device types

Class I 0Class II 2Class III 0

plus 3 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

12 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States3 registration records, 4 510(k), 0 PMA, 3 excluded

Brazil10 confirmed, 0 excluded

Manufacturer names merged into this page: ORGAN RECOVERY SYSTEMS, INC. · ORGAN RECOVERY SYSTEMS, INC. (ORS) · ORGAN RECOVERY SYSTEMS, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K091656	SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L	2010-03-11
US	K021362	LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)	2003-07-31
US	K022391	MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION	2002-10-21
BR	81827869004	LifePort Kidney Transporter	Class II
BR	81827869005	CÂNULA DESCARTÁVEL LIFEPORT KIDNEY TRANSPORTER. Acessório CAN1000 - Ac	Class II
BR	81827869006	CIRCUITO DE PERFUSÃO (COM E SEM OXIGENAÇÃO) DESCARTÁVEL LIFEPORT KIDNE	Class II

ORGAN RECOVERY SYSTEMS, 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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