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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

ADVIA 2120i with DAA Autosampler

IVDR_67_TTN_DUB-C_B_Inst_Sample Rack

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414019772
Basic UDI-DI: 0405686900784W6
Reference: 11219529
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

Tissue-Tek Genie® Controller System

Tissue-Tek Genie® Accessories (Auxiliary Products)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233002907
Basic UDI-DI: 06152338226JA
Reference: 0008008-01
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

04262392420095

Mindpeak AI Console

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Mindpeak GmbH
Manufacturer SRN: DE-MF-000031982
UDI-DI: 04262392420095
Basic UDI-DI: B-04262392420095
Reference: AIC
EMDN: W0202050392
EMDN description: LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:40

Manufacturer products View details

hema.to

1.x.y.

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: hema.to GmbH
Manufacturer SRN: DE-MF-000029988
UDI-DI: 04262375580006
Basic UDI-DI: B-04262375580006
Reference: 1.x.y
EMDN: W0202040192
EMDN description: CYTOFLOWMETERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:37

Manufacturer products View details

ARC Sterile Radial Compression Device

RCB-0048

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011333
Basic UDI-DI: 081133101RCB-0048JE
Reference: RCB-0048
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 05.08.2026 00:28

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ARC Sterile Radial Compression Device

RCB-0049

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011470
Basic UDI-DI: 081133101RCB-0049JG
Reference: RCB-0049
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 05.08.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

ARC Sterile Radial Compression Device

RCB-0047

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011494
Basic UDI-DI: 081133101RCB-0047JC
Reference: RCB-0047
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 05.08.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

CHRONO-LOG(R) Whole Blood Lumi-Aggregometer

CHRONO-LOG® Platelet Aggregation Systems

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chrono-log Corp
Manufacturer SRN: US-MF-000018631
UDI-DI: 00811476010482
Basic UDI-DI: 081147601AggregometersGT
Reference: 700-2
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: BioTop Medical
Last updated: 05.08.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

Chrono-log® Whole Blood Lumi-Aggregometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chrono-log Corp
Manufacturer SRN: US-MF-000018631
UDI-DI: 00811476010499
Basic UDI-DI: 081147601AggregometersGT
Reference: 700
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: BioTop Medical
Last updated: 05.08.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

CHRONO-LOG® Optical Aggregometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chrono-log Corp
Manufacturer SRN: US-MF-000018631
UDI-DI: 00811476010987
Basic UDI-DI: 081147601AggregometersGT
Reference: 490 4+
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: BioTop Medical
Last updated: 05.08.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

CHRONO-LOG® Optical Aggregometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chrono-log Corp
Manufacturer SRN: US-MF-000018631
UDI-DI: 00811476010994
Basic UDI-DI: 081147601AggregometersGT
Reference: 490 4+4
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: BioTop Medical
Last updated: 05.08.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

HistoCore PELORIS 3 (220-240V) Laboratory - Tissue Processor

HistoCore PELORIS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005696
Basic UDI-DI: 9349458002DB
Reference: RS45.0001
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Zebra ZD421 Label Printer Spare

IVD Class ANot specifiedOn the market

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005627
Basic UDI-DI: 9349458001D9
Reference: S21.4632
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

BOND-ADVANCE Terminal (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458005467
Basic UDI-DI: 9349458001D9
Reference: S21.4622
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BOND Controller (6.0/W10 loT)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Leica Biosystems Melbourne Pty Ltd
Manufacturer SRN: AU-MF-000016740
UDI-DI: 09349458004859
Basic UDI-DI: 9349458001D9
Reference: S21.4621
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: CEpartner4U
Last updated: 04.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

TintoStainer Plus LX Automated System

BSB-7400-60

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914672
Basic UDI-DI: 697550352BSB7400LXYU
Reference: BSB-7400-60
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

TintoStainer Plus Mini Automated System

BSB-7400-10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914665
Basic UDI-DI: 697550352BSB7400MINI2G
Reference: BSB-7400-10
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

Motic

Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160657
Basic UDI-DI: 697396716Microscope001BG
Reference: BA310E
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details