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77 Elektronika Kft.

Hungary · Budapest · en.e77.hu

✓ Record-verifiedregistrations found in 10 marketsEU SRN HU-PR-000004110

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 10 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

40UDI-DI device records

Class IIa 4IVD A 31IVD C 5

USUnited StatesFDA openFDA

2listed device types

Class I 1Class II 1Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

8registered device records

IVD A 3IVD general 5

BRBrazilANVISA

6registered devices

Class 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

5active device licences

Class II 5

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 2 1

HKHong KongMDACS

2valid listings

IVD B 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 2Class 2a 8

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 Union42 raw hits, 2 excluded, 40 confirmed

United States2 registration records, 0 510(k), 0 PMA

United Kingdom8 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: 77 ELEKTRONIKA KFT. · 77 ELEKTRONIKA MUSZERIPARI KFT. · 77 ELEKTRONIKA MÜSZERIPARI KFT

Regulatory identity

EU manufacturer SRN: HU-PR-000004110
UK responsible person: A. Menarini Diagnostics Ltd.

Business registration

LEI: 8945009GFFJ8KXHYMK68
Registration status: Active
Legal form: Korlátolt felelősségű társaság (Kft.)
Incorporated: 1989-03-08
Registration authority: National Company Register and Company Information System, no. 01-09-061328
Registry record updated: 2026-05-24

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05997345782874	Dcont ROLL Kit	Class IIa
EU	05997345782867	Dcont ETALON B Kit	Class IIa
EU	05997345782850	Dcont NOVUM Kit	Class IIa
EU	05997345782881	ETALON Teszt	IVD C
UK	47345	D-Dimer test kit	IVD general
UK	48014	SmartTester Rapid Test Reader	IVD A
UK	48014	Smart Tester Rapid Test Reader	IVD general
BR	80001590011	Analisador de Urina Urised Smart	Class II
BR	80001590010	Família de Analisadores de Urina Labumat	Class II
BR	10071770845	FAMÍLIA URISED ANALISADORES DE URINA	Class II
CA	81006	URISED URINE SEDIMENT ANALYZER	Class II
CA	81007	AUTOMATED URINE ANALYZER	Class II
CA	81123	LABSTRIP U11 PLUS	Class II

77 Elektronika Kft.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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