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Home›Hungary›B.BRAUN MEDICAL KFT

B.BRAUN MEDICAL KFT

Hungary
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
67listed device types
Class I 14Class II 51Class III 0unclassified 2
plus 293 registration records and 151 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class I 16Class II 15
42 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States293 registration records, 151 510(k), 0 PMA, 28 excluded
Brazil31 confirmed, 20 excluded
Saudi Arabia0 confirmed, 5 excluded
Canada24 confirmed, 8 excluded
Manufacturer names merged into this page: B. BRAUN MEDICAL INC. · B. Braun Medical S.A. · B. Braun Medical AG · B. BRAUN MEDICAL AG · B. BRAUN MEDICAL SAS · B BRAUN MEDICAL AG
Same-named companies — This database also contains companies with near-identical names: B.Braun Medical Kft Production Division. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Hungary

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 67
Medical Device Data System 1Syringe, Irrigating (Non Dental) 1Label Or Tag, Sterile 1Stand, Infusion 1Dispenser, Liquid Medication 1System, Hemodialysis, Remote Accessories 1Dressing Change Tray 1Needle, Catheter 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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