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

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BF-FDTI Lyse

200mL, 500mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577856
Basic UDI-DI: 69422022W010301010506R082
Reference: 3019973
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BF-WFL Lyse

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577849
Basic UDI-DI: 69422022W010301010510R07B
Reference: 3019978
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BF-FDT Lyse

500mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577818
Basic UDI-DI: 69422022W010301010503R07K
Reference: 3019938
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BF-WNL Lyse

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577764
Basic UDI-DI: 69422022W010301010511R07G
Reference: 3019960
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BF-CRP Lyse

200mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577757
Basic UDI-DI: 69422022W010301010509R08H
Reference: 3019904
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCC-3D Lyse

500mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577726
Basic UDI-DI: 69422022W010301010507R087
Reference: 3019949
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse

500mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577603
Basic UDI-DI: 69422022W010301010501R079
Reference: 3019937
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302766
Basic UDI-DI: 69368953HAL132R5
Reference: SFL 500mL（10103）
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302759
Basic UDI-DI: 69368953HAD133PF
Reference: 10×SFL-1 2L（10106）
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Reagent Kit

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175046249
Basic UDI-DI: 6934175002B0030NY
Reference: 12600777
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

06934175010288

iCARE-2100

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175010288
Basic UDI-DI: 6934175002A0001NE
Reference: 3V001
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

BF-WFF Dye

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577641
Basic UDI-DI: 69257945W0103010199R0PF
Reference: 3019941
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cleanser(BCC-3000)

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501684
Basic UDI-DI: 69257945W0103010105R0LU
Reference: 3002433
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Diatro•Hypoclean

D701

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586204
Basic UDI-DI: 5999883586HYPY9
Reference: D7011
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

Manufacturer products View details

BioStain RET fluorescent reticulocyte 12mL

BioStain RET

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366629
Basic UDI-DI: 5999862176BioStainRETAK
Reference: S021
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioStain NRBC fluorescent NRBC 12mL

BioStain NRBC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366612
Basic UDI-DI: 5999862366BioStainNRBCZT
Reference: S024
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioStain W5P fluorescent WBC-5-diff dye 42mL

BioStain W5P

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366605
Basic UDI-DI: 5999862366BioStainW5PB4
Reference: S028
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioLyse W5P WBC-5-diff lysing reagent 5L

BioLyse W5P

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366599
Basic UDI-DI: 5999862366BioLyseW5PP8
Reference: L027
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioLyse NRBC NRBC specific lysing reagent 1L

BioLyse NRBC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366582
Basic UDI-DI: 5999862366BioLyseNRBC96
Reference: L021
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details

BioDil RET reticulocyte buffer 1L

BioDil RET

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bioxol Kft
Manufacturer SRN: HU-MF-000025409
UDI-DI: 05999862366575
Basic UDI-DI: 5999862366BioDilRETZA
Reference: BioDil RET reticulocyte buffer 1L
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

Manufacturer products View details