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Fresenius Hemocare, Inc.

Germany · Redmond

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 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

6listed device types

Class I 2Class II 3Class III 0unclassified 1

plus 11 registration records and 0 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

81 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

4 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States11 registration records, 0 510(k), 21 PMA

Brazil8 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: FRESENIUS HEMOCARE GMBH · FRESENIUS HEMOCARE · FRESENIUS HEMOCARE BRASIL LTDA.

Same-named companies — This database also contains companies with near-identical names: FRESENIUS HEMOCARE BRASIL LTDA.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

Supplies, Blood-Bank 1Device, Blood Mixing And Blood Weighing 1Apparatus, Autotransfusion 1Set, Transfer (Blood/Plasma) 1Hematocrit, Tube, Rack, Sealer, Holder 1Separator, Automated, Blood Cell And Plasma, Therapeutic 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10154459023	COMPOGUARD	Class I
BR	10154459016	HEMOLIGHT PLUS	Class I
BR	10154459013	HEMOPRESS	Class I
CA	8092	IMMUNOSORBA SYSTEM	Class II

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Fresenius Hemocare, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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