HomeBrazilFANEM LTDA

FANEM LTDA

Brazil · Aventura
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel, Russia — 5 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
22registered devices
Class I 9Class II 13
34 including historic records
SASaudi ArabiaSFDA
1registered 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
4registrations
RURussiaRoszdravnadzor
8active registrations
Class 1 2Class 2a 2Class 2b 4
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, 1 510(k), 0 PMA
Brazil22 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: FANEM LTDA · Fanem LTDA

Company information

Country
Brazil
City
Aventura

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

12014 · K131196

Registration details (sample)

MarketIdentifierNameClass / date
USK131196INFANT PHOTOTHERAPY BILITRON SKY 50062014-02-20
BR10224620003TENDA DE OXIGENIO 014 CAPACETE 016Class II
BR10224629017EXTRATOR DE PLASMA 232Class I
BR10224629044CENTRIFUGA BABY IClass I
SAME0000002916SFDAA00009Hospital Baby Bassinet

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