HomeGermanyCompumedics Germany GmbH

Compumedics Germany GmbH

Germany · Singen Baden-Wurttemberg
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Australia, Hong Kong, Russia — 7 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 0Class II 2Class III 0
plus 1 registration records and 1 510(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
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
4valid listings
Class II 4
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States1 registration records, 1 510(k), 0 PMA, 6 excluded
Brazil3 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Compumedics Germany GmbH · COMPUMEDICS GERMANY GMBH

Company information

Country
Germany
City
Singen Baden-Wurttemberg

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

12005 · K051085

FDA listed device types

System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK051085DOPPLER-BOX2005-05-05
BR80797819005Equipamento de Diagnostico por Ultrassom EZ-Dop®Class II
BR80797819002DWLClass II
BR80797819003DWL Multi DopClass II

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