HomeGermanyBrahms GmbH

Brahms GmbH

Germany · Henningsdorf
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Australia, Russia — 4 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
this export covers Class I / II only (the cadastro route)
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
8active ARTG entries
IVD Class 1 2IVD Class 2 4IVD Class 3 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 1 3Class 2a 1
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 States0 registration records, 2 510(k), 0 PMA, 3 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: BRAHMS GMBH

Company information

Country
Germany
City
Henningsdorf

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

12016 · DEN150009
12017 · K171338

Registration details (sample)

MarketIdentifierNameClass / date
USK171338B R A H M S PCT sensitive KRYPTOR2017-05-31
USDEN150009B.R.A.H.M.S PCT sensitive KRYPTOR2016-02-20
BR80146502196Família Alinity c EthanolClass II
BR80146502277Família Alinity c TobramycinClass II
BR80254180321B·R·A·H·M·S AFP KRYPTOR DiluentClass I

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