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201 device results listed.

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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

04987562506354

HISCL HIT IgG Assay Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506354
Basic UDI-DI: 4987562HITIgGAssayA9
Reference: BB296616
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 28.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

14987562516817

CN-COAGWASHER

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562516817
Basic UDI-DI: 4987562CN-COAGWASHER7C
Reference: AZ700649
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:43

Manufacturer products Authorised representative products Authorised representative actors View details

14987562509550

CA CLEAN II

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509550
Basic UDI-DI: 4987562CACLEANIIG6
Reference: CJ038739
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:43

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: 14987562509079
Basic UDI-DI: 4987562STROMATOLYSER4DLCC
Reference: 054-3321-2
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:43

Manufacturer products Authorised representative products Authorised representative actors View details

14987562505309

Lysercell WDF II

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562505309
Basic UDI-DI: 4987562LysercellWDFII2L
Reference: BY541589
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:43

Manufacturer products Authorised representative products Authorised representative actors View details

04987562506385

HISCL Diluent 4

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506385
Basic UDI-DI: 4987562HISCLDiluent4TT
Reference: AY334828
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

04987562506378

HISCL HIT IgG Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506378
Basic UDI-DI: 4987562HITIgGCalDM
Reference: AR941147
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

04987562506361

HISCL HIT IgG Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506361
Basic UDI-DI: 4987562HITIgGCont9L
Reference: CL306546
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

D-CW6792878P

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CW6792878P
Basic UDI-DI: B-CW6792878P
Reference: CW679287
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-CU2486464X

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CU2486464X
Basic UDI-DI: B-CU2486464X
Reference: CU248646
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-CT7029734B

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CT7029734B
Basic UDI-DI: B-CT7029734B
Reference: CT702973
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

D-CQ5771023F

HISCL β-Amyloid 1-42 Assay kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CQ5771023F
Basic UDI-DI: B-CQ5771023F
Reference: CQ577102
EMDN: W0102019014
EMDN description: BETA-AMYLOID (1-42)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 07:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-CN383000Y5

UF-Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CN383000Y5
Basic UDI-DI: B-CN383000Y5
Reference: CN383000
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-CL552365XY

e-CHECK(XS)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CL552365XY
Basic UDI-DI: B-CL552365XY
Reference: CL552365
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 05:07

Manufacturer products Authorised representative products Authorised representative actors View details

XR-10

XR-Series Automated Hematology Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CF730361U8
Basic UDI-DI: B-CF730361U8
Reference: CF730361
EMDN: W02029080
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 04:02

Manufacturer products Authorised representative products Authorised representative actors View details

D-CC211992RE

XN-L CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CC211992RE
Basic UDI-DI: B-CC211992RE
Reference: CC211992
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-BV4191423U

HISCL β-Amyloid 1-40 Assay kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BV4191423U
Basic UDI-DI: B-BV4191423U
Reference: BV419142
EMDN: W0102019013
EMDN description: BETA-AMYLOID (1-40)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-BS6605463P

XN-L CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BS6605463P
Basic UDI-DI: B-BS6605463P
Reference: BS660546
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-BS4858985Q

EIGHTCHECK-3WP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BS4858985Q
Basic UDI-DI: B-BS4858985Q
Reference: BS485898
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details