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Home›Spain›SOFTWARE NEMOTEC, S.L.

SOFTWARE NEMOTEC, S.L.

Spain · Leganes Madrid
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Singapore — 3 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 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
1device registrations
CLASS B 1
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 States5 registration records, 5 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SOFTWARE NEMOTEC, S.L.

Company information

Country
Spain
City
Leganes Madrid

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

12019 · K192571
22020 · K193003
12023 · K232549
12024 · K232698

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Orthodontic Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232698NemoScan2024-01-18
USK232549NemoCast2023-11-21
USK193003NemoCast2020-06-05
BR80108910114SOFTWARE NEMOSTUDIOClass II

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