HomeBrazilFABINJECT INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO LTDA - EPP

FABINJECT INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO LTDA - EPP

Brazil · Taubate Sao Paulo
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
13registered devices
Class I 6Class II 7
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
pendingnot queried
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, 1 510(k), 0 PMA, 1 excluded
Brazil13 confirmed, 1 excluded
Manufacturer names merged into this page: FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA · FABINJECT INDÚSTRIA E COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO LTDA - EPP

Company information

Country
Brazil
City
Taubate Sao Paulo

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

12024 · K242132

FDA listed device types

Cannula, Surgical, General & Plastic Surgery 1Pack, Hot Or Cold, Reusable 1Transilluminator, Battery-Powered 1Powered Laser Surgical Instrument 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242132FREDDO2024-10-18
BR80213730021CAUTERMAXClass II
BR80213730022CapelliClass I
BR80213730013VEIN FINDERClass I

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