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FENWAL, INC.

USA · Lake Zurich

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 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

26listed device types

Class I 10Class II 15Class III 0unclassified 1

plus 110 registration records and 3 510(k), 6 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 6Class III 1

8 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 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 States110 registration records, 3 510(k), 6 PMA, 3 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: FENWAL, INC.

FDA 510(k) clearances by year

12008 · K073339

12012 · K111702

12014 · K141019

FDA listed device types

showing 8 of 26

Separator, Automated, Blood Cell, Diagnostic 1Blood Establishment Computer Software And Accessories 1System, Processing For Frozen Blood 1Set, Blood Transfusion 1Bone Marrow Collection/Transfusion Kit 1Pump, Infusion 1Set, I.V. Fluid Transfer 1Apparatus, Autotransfusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141019	AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED	2014-06-10
US	K111702	AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE	2012-03-22
US	K073339	BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR	2008-03-03
CA	6853	CLOSED SYSTEM APHERESIS KIT	Class II
CA	1429	OPEN/CLOSED SYSTEM APHERESIS KIT	Class III
CA	1436	BLOOD PACK UNIT WITH ACD	Class II

FENWAL, 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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