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FRESENIUS KABI AB

Sweden · Bad Homburg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

20listed device types

Class I 5Class II 10Class III 4unclassified 1

plus 58 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

101registered devices

Class I 21Class II 80

149 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

13active device licences

Class II 11Class III 2

71 including historic records

TWTaiwanTFDA

33valid device licences

Class I 7Class II 26

SGSingaporeHSA SMDR

39device registrations

CLASS B 20CLASS C 18CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

127active ARTG entries

Class I 26Class III 2IVD Class 1 1IIa 39IIb 41Class Is (sterile) 18

HKHong KongMDACS

23valid listings

Class II 10Class III 12Class IV 1

ILIsraelAMAR

39registrations

RURussiaRoszdravnadzor

77active registrations

Class 1 3Class 2a 41Class 2b 29Class 3 4

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 States58 registration records, 17 510(k), 0 PMA, 3 excluded

Brazil101 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada13 confirmed, 0 excluded

Manufacturer names merged into this page: FRESENIUS KABI WARRENDALE · Fresenius Kabi USA, LLC · FRESENIUS KABI AB · FRESENIUS KABI AUSTRIA GMBH · FRESENIUS KABI AG · FRESENIUS KABI BRASIL LTDA

FDA 510(k) clearances by year

12006

12013

22016

22018

22019

12020

12021

42022

22023

12026

FDA listed device types

showing 8 of 20

Catheter, Peripheral, Atherectomy 1Separator, Automated, Blood Cell, Diagnostic 1Blood Establishment Computer Software And Accessories 1System And Accessories, Isolated Heart, Transport And Preservation 1Set, Perfusion, Kidney, Disposable 1Pump, Infusion 1Set, I.V. Fluid Transfer 1Set, Administration, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251139	KabiHelp® Uno; KabiHelp® Advance plus	2026-01-09
US	K221121	Volumat Polyethylene I.V. Administration Set	2023-06-16
US	K220301	Volumat Line	2023-06-02
BR	10004100022	FREKA-SONDA ENTERAL	Class II
BR	10004100147	FREKA PAED CH 6,5	Class II
BR	10004100145	FREKA SONDA ENTERAL CH 15	Class II
SA	ME0000001822SFDAA00067	CONOX SENSOR	—
SA	ME0000002223SFDAA00012	Link+ Agilia RS232 cable	—
CA	32734	PERFUDROP SET	Class II
CA	9879	IV BLOOD ADMINISTRATION SET	Class II
CA	61056	COMPOMAT G4	Class II

FRESENIUS KABI AB

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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