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CompoLab TM Plus

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: EKF-diagnostic GmbH
Manufacturer SRN: DE-MF-000006416
UDI-DI: 04048534002394
Basic UDI-DI: 4048534DEAAVR
Reference: 9035500
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 08.08.2026 18:28

Manufacturer products View details

LYSUN

BHM-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209005
Basic UDI-DI: 697177120BHM101B3
Reference: BHM-101
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 08.08.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

LordsMed 3 Part Haematology Analyser

LM001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470006
Basic UDI-DI: 890619447LM001EX
Reference: LM001
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Konan CellChek D CD-15

N/A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Konan Medical, Inc.
Manufacturer SRN: JP-MF-000005193
UDI-DI: 04582275250404
Basic UDI-DI: 458227526KONAN-ESPLB
Reference: N/A
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Malta
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S360MD Slide scanner system

C13220-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010697
Basic UDI-DI: 4582389NNZM36001MU
Reference: C13220-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S20MD Slide scanner system

C16300-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010741
Basic UDI-DI: 4582389NNZM02001KX
Reference: C16300-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S60v2MD Slide scanner system

IVD Class ANot specifiedOn the market

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389010789
Basic UDI-DI: 4582389NNZM06001LT
Reference: C16600-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

NanoZoomer S540MD Slide scanner system

C17400-21MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389011212
Basic UDI-DI: 4582389NNZM54001N4
Reference: C17400-21MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Agilent S540MD Slide Scanner System

C17400-51MDEU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hamamatsu Photonics K.K., Systems Division
Manufacturer SRN: JP-MF-000019003
UDI-DI: 04582389011328
Basic UDI-DI: 4582389AGIL54001X3
Reference: C17400-51MDEU
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Denmark
Authorised representative: Hamamatsu Photonics Deutschland GmbH
Last updated: 07.08.2026 17:38

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Automated Coverslipper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270166
Basic UDI-DI: 697756827004R9
Reference: CV610
EMDN: W0202059008
EMDN description: AUTOMATED COVERSLIPPERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270142
Basic UDI-DI: 697756827AS7G
Reference: ST510
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

06976556565314

ESR RACK

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Weihai Sunway Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000025939
UDI-DI: 06976556565314
Basic UDI-DI: 697655656RACK001YW
Reference: QI-7.5.8-02
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Coverslipper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568271163
Basic UDI-DI: 697756827004R9
Reference: CV610S
EMDN: W0202059008
EMDN description: AUTOMATED COVERSLIPPERS
First on market country: -
Authorised representative: MedPath GmbH
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Immage Navigator®

IN110

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Immuno Concepts N.A., Ltd.
Manufacturer SRN: US-MF-000054193
UDI-DI: M74900IN1101
Basic UDI-DI: ++M749INFW
Reference: IN110
EMDN: W0202050382
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 06.08.2026 18:14

Manufacturer products Authorised representative products Authorised representative actors View details

SPINCELL 5 Plus

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950736
Basic UDI-DI: B-08431673950736
Reference: 5006103
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

Autoloader

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586990
Basic UDI-DI: 5999883586A5XW
Reference: AS5-1
EMDN: W0202010180
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Hungary
Authorised representative: -
Last updated: 05.08.2026 19:51

Manufacturer products View details

Cell ‐ Count 5/60

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586976
Basic UDI-DI: 5999883586A5XW
Reference: EMS 501
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 05.08.2026 19:26

Manufacturer products View details

Abacus 5 Hematology Analyzer

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586327
Basic UDI-DI: 5999883586A5XW
Reference: A5-1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 05.08.2026 18:46

Manufacturer products View details

Abacus 5 Hematology Analyzer

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586297
Basic UDI-DI: 5999883586A5XW
Reference: A5-1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 05.08.2026 16:13

Manufacturer products View details

ADVIA 2120i without Autosampler

IVDR_67_TTN_DUB-C_B_Inst _No Sample Rack

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414019796
Basic UDI-DI: 0405686900768W8
Reference: 11219531
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details