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PANNORAMIC 250 Flash III DX Digital Scanner

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: 3DHISTECH Kft.
Manufacturer SRN: HU-MF-000014337
UDI-DI: 05999571470167
Basic UDI-DI: 5999571470266JC
Reference: DX-02503-F1205ACBA
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 16:39

Manufacturer products View details

Case Manager DX

CaseManager DX

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: 3DHISTECH Kft.
Manufacturer SRN: HU-MF-000014337
UDI-DI: 05999571470150
Basic UDI-DI: 599957147155SE
Reference: DX-CASEM-0
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 16:39

Manufacturer products View details

PANNORAMIC 1000 DX Digital Scanner

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: 3DHISTECH Kft.
Manufacturer SRN: HU-MF-000014337
UDI-DI: 05999571470129
Basic UDI-DI: 599957147046S8
Reference: DX-10001-B1200AAAA
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:39

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NanoTYPER

IVD Class CIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781354
Basic UDI-DI: 599956578002TX
Reference: SW6
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:38

Manufacturer products View details

Norma i3LAB automated 3-part differential hematology analyzer

Norma i3LAB

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200351
Basic UDI-DI: 59991062i3LAB2K
Reference: NI31H
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:36

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Norma Autoloader accessory unit for automated sample vial loading

Norma Autoloader

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200047
Basic UDI-DI: 59991062AutoloaderGH
Reference: NICA-AL50
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

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Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method

Norma Icon-5 OP

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200023
Basic UDI-DI: 59991062Icon5OPU7
Reference: NO50H
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method

Norma Icon-5

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200016
Basic UDI-DI: 59991062Icon5A6
Reference: NI50H
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

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Norma Icon-3 automated 3-part differential hematology analyzer

Norma Icon-3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200009
Basic UDI-DI: 59991062Icon3A2
Reference: NI30H
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

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Dcont ETALON Kit

Blood glucose meter kit - Dcont ETALON family

Class IIaMDR 2017/745On the market

Manufacturer: 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-PR-000004110
UDI-DI: 05997345782843
Basic UDI-DI: 59973457DEV8K
Reference: D71-9901
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Dcont ROLL

Dcont ETALON

IVD Class CIVDR 2017/746On the marketInstrumentSelf testing

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345782171
Basic UDI-DI: 59973457DEK7V
Reference: D75-800100
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Safety summary (SSCP/SSP): SSP Dcont ETALON (D71) and variants, ETALON Teszt test strip v2 · Rev. 6
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products Open in EUDAMED View details

DocUReader 2 Pro

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345781211
Basic UDI-DI: 59973457SAUA4S
Reference: 49874
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

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SmartTester

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345779775
Basic UDI-DI: 59973457SAUASRTGB
Reference: STR-9901-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

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UriSed Cuvettes

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345779577
Basic UDI-DI: 59973457CUV9W
Reference: URS-9961CH-1
EMDN: W02010785
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

LabUReader Plus 2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: 77 Elektronika Műszeripari Kft
Manufacturer SRN: HU-MF-000004266
UDI-DI: 05997345779515
Basic UDI-DI: 59973457SAUALABCH
Reference: UA3-9901-2
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Cellagon 5 Pro Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000332
Basic UDI-DI: 599279505WR
Reference: g-Cell5Pro
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Cellagon 3 Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000318
Basic UDI-DI: 599279503WM
Reference: g-Cell 3
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Coag M automated coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000301
Basic UDI-DI: 599279506WT
Reference: g-CoagM
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

HemOcular Slide Reader

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000257
Basic UDI-DI: 599279507WV
Reference: g-Hemocular
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Coag L automated coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000240
Basic UDI-DI: 599279508WX
Reference: g-CoagL
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details