HomeGermanySOMATEX Medical Technologies GmbH

SOMATEX Medical Technologies GmbH

Germany · Berlin
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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 10 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class 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
3 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
3valid listings
Class II 1Class III 2
ILIsraelAMAR
12registrations
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 States10 registration records, 7 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: SOMATEX Medical Technologies GmbH · SOMATEX MEDICAL TECHNOLOGIES GMBH

Company information

Country
Germany
City
Berlin

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

12008 · K073095
12010 · K093064
22011 · K111692
22018 · K182082
12021 · K201863

FDA listed device types

Needle, Tumor Localization 1Marker, Radiographic, Implantable 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape2021-02-18
USK182082Tumark for Eviva, Tumark for Brevera2018-10-31
USK180443Tumark Vision2018-03-22
BR10337850095Cânulas pra Marcação de Nódulos RMClass II
BR10337850096Cânulas para Marcação de NódulosClass II
BR10337850099CÂNULA PARA MARCAÇÃO DE NÓDULO PULMONARClass II

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