HomeEgyptAmeco Medical Industries SAE

Ameco Medical Industries SAE

Egypt · Ramadan - Cairo · www.amecathgroup.com
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, South Korea, Israel — 6 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
0UDI-DI device records
USUnited StatesFDA openFDA
16listed device types
Class I 9Class II 7Class III 0
plus 17 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class III 1
BRBrazilANVISA
85registered devices
Class I 11Class II 74
87 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States17 registration records, 6 510(k), 0 PMA
United Kingdom1 confirmed, 1 excluded
Brazil85 confirmed, 0 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: AMECO MEDICAL INDUSTRIES

Regulatory identity

UK responsible person
IMed Consultancy Ltd

Company information

Country
Egypt
City
Ramadan - Cairo
Website
www.amecathgroup.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

22011 · K110794
32013 · K131144
12016 · K152819

FDA listed device types

showing 8 of 16
Device, Cystometric, Hydraulic 1Dislodger, Stone, Basket, Ureteral, Metal 1Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Catheter, Hemodialysis, Non-Implanted 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Catheter, Hemodialysis, Implanted 1Introducer, Catheter 1Dilator, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
UK10729Adult Dual Lumen Central Venous Catheter KitsClass III
USK152819Amecath Peripheral inserted Central Venous Catheter Sets2016-02-05
USK131144AMECO SHEATH INTRODUCER2013-08-15
USK131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER2013-07-26
BR81665699036KIT CATETER DUPLO J - SP KH0Class II
BR81665699019Cateter UreteralClass II
BR80250540035FIO GUIA EM AÇO INOXIDÁVEL COM COBERTURA HIDROFÍLICAClass II

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