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B. BRAUN MELSUNGEN AG

Germany · Melsungen

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 4Class II 21Class III 0unclassified 1

plus 63 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

56registered devices

Class I 12Class II 44

78 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

34active device licences

Class II 28Class III 5Class IV 1

74 including historic records

TWTaiwanTFDA

18valid device licences

Class II 17Class III 1

SGSingaporeHSA SMDR

108device registrations

CLASS B 81CLASS C 13CLASS D 10D WITH MEDICINAL PRODUCT 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

98active ARTG entries

Class I 18Class III 14IIa 36IIb 17Class Is (sterile) 13

HKHong KongMDACS

46valid listings

Class II 26Class III 6Class IV 14

ILIsraelAMAR

72registrations

RURussiaRoszdravnadzor

62active registrations

Class 1 8Class 2a 31Class 2b 14Class 3 9

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 States63 registration records, 5 510(k), 0 PMA

Brazil56 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada34 confirmed, 0 excluded

Manufacturer names merged into this page: B. BRAUN MELSUNGEN AG · B. BRAUN MELSUNGEN AG, OPM · B.BRAUN MELSUNGEN AG · B.BRAUN MELSUNGEN AG · B. BRAUN MELSUNGEN · B.Braun Melsungen AG

FDA 510(k) clearances by year

22011 · K111236

12013 · K131040

12016 · K152050

12017 · K163358

FDA listed device types

showing 8 of 26

Needle, Conduction, Anesthetic (W/Wo Introducer) 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Bottle, Collection, Vacuum 1Needle, Hypodermic, Single Lumen 1System, Dialysate Delivery, Central Multiple Patient 1Catheter, Conduction, Anesthetic 1Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact 1Anesthesia Conduction Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163358	Introcan Safety 3 Closed IV Catheter	2017-04-28
US	K152050	Pencylcap	2016-03-02
US	K131040	EXTAVIPRO STERICAN 30G	2013-07-15
BR	10008530247	PERFUSOR SET PE - DISPOSITIVO PARA A EXTENSAO DEEQUIPOS	Class II
BR	10008530240	TRANSOFIX - SISTEMA DE TRANSFERENCIA PARA FLUIDOSESTEREIS	Class I
BR	10008530113	IN STOPPER ( Tapon in ) - TAMPA COM MEMBRANA SEM LATEX PARA INJECOES I	Class II
SA	ME0000003035SFDAA00025	Perifix Catheter Connector Sleeve	—
CA	4954	LS-CONNECTORS	Class II
CA	10183	LIVER BIOPSY SET	Class II
CA	13060	IRRIGATION SYRINGES	Class II