HomeArgentinaNUXEN SRL

NUXEN SRL

Argentina · Buenos Aires
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, 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
9registered devices
Class II 9
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered 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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States0 registration records, 2 510(k), 0 PMA
Brazil9 confirmed, 0 excluded
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: NUXEN SRL · Nuxen S.R.L

Company information

Country
Argentina
City
Buenos Aires

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

22012 · K113608

Registration details (sample)

MarketIdentifierNameClass / date
USK113608DEFLEX2012-04-10
USK113788DEFLEX ACRILATO2012-03-16
BR80383780002DEFLEX - ACRILATO FDClass II
BR80383789004DEFLEX PEEKClass II
BR80383780004DEFLEX ACETAL ACClass II
SAME0000007001SFDAA00003M10 XR
SAME0000007001SFDAA00009BULKFLEX TENAZ

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