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B. BRAUN AVITUM AG

Germany · Melsungen

✓ Record-verifiedregistrations found in 10 markets

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

12listed device types

Class I 2Class II 10Class III 0

plus 30 registration records and 5 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

58registered devices

Class I 8Class II 50

70 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

38 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

25device registrations

CLASS B 9CLASS C 16

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

23active ARTG entries

Class I 4IIa 10IIb 8Class Is (sterile) 1

HKHong KongMDACS

5valid listings

Class II 1Class III 4

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

31active registrations

Class 1 2Class 2a 9Class 2b 16Class 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 States30 registration records, 5 510(k), 21 PMA

Brazil58 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: B. BRAUN AVITUM AG · B. Braun Avitum AG · B. Braun Avitum Saxonia GmbH · B. Braun Avitum Italy S.p.A. · B. BRAUN AVITUM ITALY S.P.A. · B.Braun Avitum AG

FDA 510(k) clearances by year

22010 · K100334

12011 · K102194

12016 · K143482

12017 · K170574

FDA listed device types

showing 8 of 12

Subsystem, Water Purification 1Pump, Infusion, Pca 1Pump, Infusion, Enteral 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Pump, Infusion 1Set, I.V. Fluid Transfer 1System/Device, Pharmacy Compounding 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170574	Diacap Pro Dialyzer	2017-08-11
US	K143482	xevonta dialyzer	2016-03-01
US	K102194	SOLCART B	2011-04-25
BR	80136990830	KIT PARA ADSORÇÃO/PERFUSÃO DE PLASMA PARA DIAPACT CRRT	Class II
BR	80136990453	LINHA DE SANGUE PARA TRANSPORTE DE SANGUE ARTERIAL EM TERAPIA DE HEMOD	Class II
BR	80136990454	LINHA DE SANGUE PARA TRANSPORTE DE SANGUE VENOSO EM TERAPIA DE HEMODIA	Class II
CA	78202	PUMP DAY CASSETTES FOR ARTHROSCOPY SURGERY	Class II
CA	78203	PUMP PATIENT CASSETTES FOR ARTHROSCOPY SURGERY	Class II
CA	78435	ARTHROSCOPY IRRIGATION TUBING SETS	Class II