HomeHungaryEMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.

EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.

Hungary · Debrecen Hajdu-Bihar
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 3 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 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 2Class II 6
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
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 States1 registration records, 1 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT. · EMD ENDOSZKÓP MUSZER GYÁRTO ÉS KERESKEDELMI KFT

Company information

Country
Hungary
City
Debrecen Hajdu-Bihar

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

12022 · K213228

FDA listed device types

Drills, Burrs, Trephines & Accessories (Compound, Powered) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213228NeuroLine Disposable Cranial Perforator with Hudson end2022-06-20
BR80703839006BROCA AUTOMÁTICA NEUROLINE PEDIÁTRICAClass II
BR80703839007BROCA AUTOMÁTICA NEUROLINE ADULTOClass II
BR80703839008Instrumentos Descartáveis de Alta Velocidade NeuroLineClass II

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