HomeMalaysiaB. BRAUN MEDICAL INDUSTRIES SDN. BHD.

B. BRAUN MEDICAL INDUSTRIES SDN. BHD.

Malaysia · Penang Pulau Pinang
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 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
142listed device types
Class I 85Class II 55Class III 0unclassified 2
plus 387 registration records and 151 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
30registered devices
Class I 17Class II 13
41 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
5GMP quality-system certificates
Import 5
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 States387 registration records, 151 510(k), 0 PMA, 27 excluded
Brazil30 confirmed, 21 excluded
Saudi Arabia0 confirmed, 5 excluded
Canada24 confirmed, 8 excluded
Manufacturer names merged into this page: B. BRAUN MEDICAL INC. · B. BRAUN MEDICAL INDUSTRIES SDN. BHD. · B. Braun Medical S.A. · B. Braun Medical AG · B. BRAUN MEDICAL AG · B. BRAUN MEDICAL SAS

Company information

Country
Malaysia
City
Penang Pulau Pinang

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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 142
System, Hemodialysis, Remote Accessories 1Needle, Aspiration And Injection, Disposable 1Catheter, Infusion 1Orthopedic Manual Surgical Instrument 1Accessories, Catheter 1Syringe, Irrigating (Non Dental) 1Retractor, Ent 1Extractor 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253235Introcan Safety® Deep Access XL IV Catheter2026-05-15
USK243392Infusomat® Space Volumetric Infusion Pump Administration Sets2025-07-24
USK240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System2024-07-31
BR10008530202SERINGA PERFUSORA - SERINGA PARA UTILIZACAO EM BOMBAS DE SERINGA TIPO Class II
BR10008530137TORNEIRA DE 3 VIAS PARA INFUSAO E MEDICAO DA PRESSAO FISIOLOGICAClass II
BR80136990452FAMILIA DE TORNEIRA EM TRES VIASClass II
CA30723FINAL FILTERSClass II
CA76626BINARY CONNECTORClass II
CA76628INSULIN SYRINGESClass II

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