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B. BRAUN MEDICAL A G

Switzerland

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

159listed device types

Class I 98Class II 59Class III 0unclassified 2

plus 424 registration records and 151 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

33registered devices

Class I 18Class II 15

47 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

24active device licences

Class II 19Class III 4Class IV 1

115 including historic records

TWTaiwanTFDA

6valid device licences

Class I 2Class II 4

SGSingaporeHSA SMDR

8device registrations

CLASS B 2CLASS C 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

Class III 4IIb 2Class Is (sterile) 2

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

10registrations

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 States424 registration records, 151 510(k), 0 PMA, 26 excluded

Brazil33 confirmed, 18 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada24 confirmed, 8 excluded

Manufacturer names merged into this page: B.Braun Medical (Suzhou) Co,.Ltd · B. BRAUN MEDICAL INC. · B. BRAUN MEDICAL INDUSTRIES SDN. BHD. · B. Braun Medical S.A. · B. BRAUN MEDICAL AG · B. BRAUN MEDICAL SAS

FDA 510(k) clearances by year

42007

32008

72009

32010

32011

32012

22013

42014

42015

52016

42017

52018

12019

52020

22021

52022

22023

32024

12025

12026

FDA listed device types

showing 8 of 159

Chisel, Surgical, Manual 1System, Hemodialysis, Remote Accessories 1Needle, Aspiration And Injection, Disposable 1Catheter, Infusion 1Orthopedic Manual Surgical Instrument 1Accessories, Catheter 1Syringe, Irrigating (Non Dental) 1Retractor, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253235	Introcan Safety® Deep Access XL IV Catheter	2026-05-15
US	K243392	Infusomat® Space Volumetric Infusion Pump Administration Sets	2025-07-24
US	K240578	VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System	2024-07-31
BR	10008530202	SERINGA PERFUSORA - SERINGA PARA UTILIZACAO EM BOMBAS DE SERINGA TIPO	Class II
BR	10008530137	TORNEIRA DE 3 VIAS PARA INFUSAO E MEDICAO DA PRESSAO FISIOLOGICA	Class II
BR	80136990452	FAMILIA DE TORNEIRA EM TRES VIAS	Class II
CA	30723	FINAL FILTERS	Class II
CA	76626	BINARY CONNECTOR	Class II
CA	76628	INSULIN SYRINGES	Class II

B. BRAUN MEDICAL A G

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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