HomeBrazilMED TEC INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA - ME

MED TEC INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA - ME

Brazil
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
11510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 3Class II 4
21 including historic records
SASaudi ArabiaSFDA
57registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
11 including historic records
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 States0 registration records, 11 510(k), 0 PMA, 44 excluded
Brazil7 confirmed, 14 excluded
Saudi Arabia57 confirmed, 4 excluded
Canada6 confirmed, 7 excluded
Manufacturer names merged into this page: OCEAN PACIFIC MED TEC LTD. · ALIMED TEC TECNOLOGIA INSTRUMENTAL IND E COM LTDA ME · DANIALEX TEC - MATERIAL MEDICO HOSPITALAR LTDA ME · MED TEC INDUSTRIA E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA - ME · SUZHOU JH MED-TEC CO., LTD · Med-Tec Inc. bda CIVCO Medical Solutions and CIVCO Radiotherapy
Same-named companies — This database also contains companies with near-identical names: Med-Tec,Inc., OCEAN PACIFIC MED TEC LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil

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

11989
21998
12000
22002
22003
12004
12012
12013

Registration details (sample)

MarketIdentifierNameClass / date
USK132084PROTURA COUCH SOFTWARE2013-09-26
USK122201PROTURA COUCH SOFTWARE2012-08-30
USK034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO1002004-02-20
BR80826980006Caneta de baixa rotação - motorzinhoClass II
BR80826980005Caneta de Epilação à BateriaClass II
BR81923050002Equipamento para Avaliação da Acuidade Visual - Família Med Tec VAClass I
SAME0000002101SFDAA00071Monarch™ Overhead Arm Positioner
SAME0000002101SFDAA00051Bra Extender
CA64113EMS NEOPRENE HIGH RISK MEDICAL GLOVESClass II
CA64114LATEX MEDICAL EXAMINATION GLOVESClass II
CA64115NITRILE MEDICAL EXAMINATION GLOVESClass II

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