HomeHungaryNorma Instruments Zrt.

Norma Instruments Zrt.

Hungary · Budapest · www.normadiagnostika.com
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in Brazil, Israel — 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
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
20registered devices
Class I 12Class II 8
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
3registrations
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.

European Union559 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United Kingdom0 confirmed, 4 excluded
Brazil20 confirmed, 0 excluded
Manufacturer names merged into this page: NORMA INSTRUMENTS ZRT.

Company information

Country
Hungary
City
Budapest
Website
www.normadiagnostika.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulation

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR81327670013ANALISADOR AUTOMÁTICO DE HEMATOLOGIA – ICONClass II
BR81628880058Controle e calibrador para Analisador de HematologiaClass II
BR80367750001Solução do Sistema 3 DiffClass I

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