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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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pocH-pack 65XL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562510269
Basic UDI-DI: 4987562pocH-pack65XL2V
Reference: CQ-711-695
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

pocH-pack 65

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562510252
Basic UDI-DI: 4987562pocH-pack65YX
Reference: 370-0032-0
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-FB

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562510245
Basic UDI-DI: 4987562STROMATOLYSERFBMJ
Reference: 944-0461-3
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-4DL

STROMATOLYSER -4DL

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562201402
Basic UDI-DI: 4987562STROMATOLYSER4DLCC
Reference: 984-176-15
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

04987562509348

Lysercell WDF II

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562509348
Basic UDI-DI: 4987562LysercellWDFII2L
Reference: CC435438
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 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

RET-SEARCH(II)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562509133
Basic UDI-DI: 4987562RETSEARCH(II)HC
Reference: 984-1621-1
EMDN: W0103010102
EMDN description: SPECIFIC RETICULOCYTE REAGENTS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562509034

CELLCLEAN AUTO

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562509034
Basic UDI-DI: 4987562CELLCLEANAUTORU
Reference: BQ095093
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 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562499458

Lysercell M

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562499458
Basic UDI-DI: 4987562LysercellMPW
Reference: CJ-760-691
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 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562499441

Fluorocell M

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562499441
Basic UDI-DI: 4987562FluorocellM3Y
Reference: CA-006-592
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562497607

CyLyse LV

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562497607
Basic UDI-DI: 4987562CyLyseLVZV
Reference: BL-215-283
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562423002

Lysercell WPC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562423002
Basic UDI-DI: 4987562LysercellWPCYG
Reference: CS-412-800
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562422999

Lysercell WDF

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562422999
Basic UDI-DI: 4987562LysercellWDFXJ
Reference: AW-993-605
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562422982

Lysercell WNR

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562422982
Basic UDI-DI: 4987562LysercellWNRZ8
Reference: AN-577-063
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562422951

CELLPACK DFL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562422951
Basic UDI-DI: 4987562CELLPACKDFLXJ
Reference: BT-965-910
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562422937

CELLPACK DST

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562422937
Basic UDI-DI: 4987562CELLPACKDSTZ9
Reference: BQ-505-775
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

CELLPACK DCL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562422906
Basic UDI-DI: 4987562CELLPACKDCLX9
Reference: CT-661-628
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 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

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

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