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CELLPACK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562020102
Basic UDI-DI: 4987562CELLPACKE5
Reference: 834-0011-6
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

CLEANAC MEK-520

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921800911
Basic UDI-DI: 4931921IVD0019P6
Reference: T438
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

ISOTONAC･3 MEK-640

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921054383
Basic UDI-DI: 4931921IVD0016NY
Reference: MEK-640-TO
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

HEMATOLOGY CONTROL+CRP MK-3CN

CONTROL BLOOD MULTILEVEL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026090
Basic UDI-DI: 4931921IVD0010NL
Reference: 3CN03
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolynac･510 MK-510W

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026045
Basic UDI-DI: 4931921IVD0018P4
Reference: T496D
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolynac･310 MK-310W

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026038
Basic UDI-DI: 4931921IVD0017P2
Reference: T493D
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

HEMATOLOGY CONTROL for reticulocyte MK-RE1

CONTROL BLOOD MULTILEVEL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921015438
Basic UDI-DI: 4931921IVD0012NQ
Reference: RE104
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

04719874742089

R10

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Bonraybio Co., LTD.
Manufacturer SRN: TW-MF-000029512
UDI-DI: 04719874742089
Basic UDI-DI: 471987474R10PR
Reference: R10
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

JaClean

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer SRN: DE-MF-000032559
UDI-DI: 04262400020545
Basic UDI-DI: 426240002CleanerZF
Reference: RG2209031
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:30

Manufacturer products View details

JetBuffer pH 7.2

JetBuffer

IVD Class AIVDR 2017/746On the marketDirect markingReagent

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer SRN: DE-MF-000032559
UDI-DI: 04262400020057
Basic UDI-DI: 426240002BufferN3
Reference: RG220900
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:30

Manufacturer products View details

Wright JetDye-AF

MGG JetDye-AF Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer SRN: DE-MF-000032559
UDI-DI: 04262400020026
Basic UDI-DI: 426240002JetDyeKE
Reference: RG2209002
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:30

Manufacturer products View details

04260531790641

V-SPERM MOPRHO SLIDE

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: VITROMED GmbH
Manufacturer SRN: DE-MF-000005131
UDI-DI: 04260531790641
Basic UDI-DI: 426053179VSMSEC
Reference: V-SMS-01
EMDN: W0103010301
EMDN description: HISTO / CYTO STAINS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:09

Manufacturer products View details

Hemafix® Blau

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: BIOMED Labordiagnostik GmbH
Manufacturer SRN: DE-MF-000010310
UDI-DI: 04260481081950
Basic UDI-DI: 426048108STA00537K
Reference: 102307
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:01

Manufacturer products View details

Hemafix® Rot

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: BIOMED Labordiagnostik GmbH
Manufacturer SRN: DE-MF-000010310
UDI-DI: 04260481081936
Basic UDI-DI: 426048108STA00527H
Reference: 102304
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:01

Manufacturer products View details

04260154340247

SP-Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Sysmex Europe SE
Manufacturer SRN: DE-MF-000022332
UDI-DI: 04260154340247
Basic UDI-DI: 426015434SP-BufferNM
Reference: 370-0030-4
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

Wright’s eosin methylene blue solution for microscopy

Wright‘s eosin methylene blue solution for microscopy

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Merck KGaA
Manufacturer SRN: DE-MF-000018777
UDI-DI: 04027269233495
Basic UDI-DI: 4027269101383U8
Reference: 1013839025
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 22:07

Manufacturer products View details

Bio-Diff komplet, 3x100 mL

Reagensi za hematologiju

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: BioGnost Ltd.
Manufacturer SRN: HR-MF-000022153
UDI-DI: 03858888822019
Basic UDI-DI: 385889212HPC3010302HMCA
Reference: BD-K-100
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Croatia
Authorised representative: -
Last updated: 30.07.2026 21:58

Manufacturer products View details

Whitediff 1L

1210906022

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004746
Basic UDI-DI: 361023whitediff4Z
Reference: 1210906022
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

ESRtrol

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009543
Basic UDI-DI: 361023esrtrolQA
Reference: 1300128293
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details

ABX Minotrol Retic

2072201, 2072202, 1300136023, 1300136026, 1300136029

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008898
Basic UDI-DI: 361023minotrol_reticB2
Reference: 2072201, 2072202, 1300136023, 1300136026, 1300136029
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:12

Manufacturer products View details