HomeGermanyHASOMED GMBH

HASOMED GMBH

Germany · Magdeburg Saxony-Anhalt
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Singapore, Australia, Israel, 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
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 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 States4 registration records, 4 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: HASOMED GMBH · HASOMED GmbH

Company information

Country
Germany
City
Magdeburg Saxony-Anhalt

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

12007 · K073237
12011 · K112844
12014 · K132416
12017 · K162683

FDA listed device types

Computerized Cognitive Assessment Aid, Exempt 1Stimulator, Neuromuscular, External Functional 1System, Communication, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK162683RehaStim 22017-02-03
USK132416REHASTIM 2, ERIGOPRO (FES)2014-05-28
USK112844REHASTIM 2, REHAMOVE 22011-10-27
BR80694819005SISTEMA DE REABILITAÇÃO COGNITIVA REHACOMClass I
SAME0000021763SFDAA00001RehaCom Keyboard
SAME0000021763SFDAA00002Rehalngest

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