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BAUMER S.A.

Brazil · Mogi Mirim - Sp Sao Paulo
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
43registered devices
Class I 36Class II 7
96 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States2 registration records, 4 510(k), 0 PMA, 2 excluded
Brazil43 confirmed, 0 excluded
Manufacturer names merged into this page: BAUMER S.A.

Company information

Country
Brazil
City
Mogi Mirim - Sp Sao Paulo

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

12000 · K001571
32001 · K011504

FDA listed device types

Cleaner, Ultrasonic, Medical Instrument 1Disinfector, Medical Devices 1

Registration details (sample)

MarketIdentifierNameClass / date
USK011504BAUMER LOCKING NAIL2001-08-14
USK003975BAUMER CEMENTED HIP PROSTHESIS2001-03-19
USK003976BAUMER MULLER HIP PROSTHESIS2001-03-19
BR10345500073FIXADOR EXTERNO DINAMICO PARA OSSOS MEDIOS E LONGOSClass I
BR10345500099ESTERILIZADOR A VAPORClass II
BR10345500050MESA CIRÚRGIA RADIOTRANSPARENTE - ATENAClass I

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