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ALLMED MIDDLE EAST

Egypt · Of October
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class II 12
15 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
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 States1 registration records, 0 510(k), 0 PMA
Brazil12 confirmed, 0 excluded
Manufacturer names merged into this page: GKB HI-TECH MIDDLE EAST · ALLMED MIDDLE EAST
Same-named companies — This database also contains companies with near-identical names: GKB HI-TECH MIDDLE EAST. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Egypt
City
Of October

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 listed device types

Lens, Spectacle (Prescription), For Reading Discomfort 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80188519004ISOLADOR DE PRESSÃO DIALINEClass II
BR80188510029Conjunto Descartável de Circulação Assistida _KIT PARA HEMODIALISE 8MMClass II
BR80188510032Conjunto Descartável de Circulação Assistida - KIT PARA HEMODIÁLISE 6MClass II

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