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261 device results listed.

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Prenatal Enumeration Probe kit

Prenatal Enumeration Probe kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906006
Basic UDI-DI: 50558449LPA001GG
Reference: CE-LPA 001-30
EMDN: W0106010301
EMDN description: DOWN'S SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal Enumeration Probe kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844905986
Basic UDI-DI: 50558449LPA001GG
Reference: CE-LPA 001
EMDN: W0106010301
EMDN description: DOWN'S SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal Enumeration Probe kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844905993
Basic UDI-DI: 50558449LPA001GG
Reference: CE-LPA 001-S
EMDN: W0106010301
EMDN description: DOWN'S SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal Enumeration Probe kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906013
Basic UDI-DI: 50558449LPA001GG
Reference: CE-LPA 001-50
EMDN: W0106010301
EMDN description: DOWN'S SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

FAST FISH Prenatal Enumeration Probe kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906075
Basic UDI-DI: 50558449LPF001HK
Reference: CE-LPF 001-S
EMDN: W0106010305
EMDN description: TURNER SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

FAST FISH Prenatal Enumeration Probe kit

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906082
Basic UDI-DI: 50558449LPF001HK
Reference: CE-LPF 001-30
EMDN: W0106010305
EMDN description: TURNER SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

FAST FISH Prenatal Enumeration Probe kit

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906099
Basic UDI-DI: 50558449LPF001HK
Reference: CE-LPF 001-50
EMDN: W0106010305
EMDN description: TURNER SYNDROME
First on market country: -
Authorised representative: Sysmex Europe SE
Last updated: 29.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

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

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

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

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

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

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

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

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