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

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06972337851355

Sheath-Sys,Sheath-Ruby,Sheath-XN

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337851355
Basic UDI-DI: 697233785Sheath022NM
Reference: Sheath-Ruby 20L
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

CellCleaner (Detergent Rinse)

CellClean (Detergent、Rinse)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337850068
Basic UDI-DI: 697233785Cleaner005MR
Reference: 1360
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450619

DxLab-2A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450619
Basic UDI-DI: 697222145061FJ
Reference: DxLab-2A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450596

RTisochip-W

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450596
Basic UDI-DI: 697222145059FX
Reference: RTisochip-W
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450480

RTisochipTM-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450480
Basic UDI-DI: 697222145048FS
Reference: RTisochipTM-A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06972221450381

LuxScan 10K/A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000027694
UDI-DI: 06972221450381
Basic UDI-DI: 697222145038FP
Reference: LuxScan 10K/A
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

G-3LHB Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152263
Basic UDI-DI: 697122593GS61165D6
Reference: G-3LHB
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

G-3DIL Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152256
Basic UDI-DI: 697122593GS58237GMZ
Reference: G-3DIL
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cleanser

CLR:500 mL

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117452527
Basic UDI-DI: 697049309W010200000069F
Reference: 12.02.0644A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

D-80LD:1L

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117452046
Basic UDI-DI: 697049309W010300000029S
Reference: 12.01.1913A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analysis Reagent Kit

PFD-1A 50 tests/kit

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306460
Basic UDI-DI: 697049309W01030000028AC
Reference: PO-0030-01
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377302820
Basic UDI-DI: 697049309W01030000023A2
Reference: XQ-0067-01
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Dye

D-80FN(M) 6mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377302806
Basic UDI-DI: 697049309W01030000029AE
Reference: XQ-0064-02
EMDN: W0103010199
EMDN description: REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Dye

D-80FR(M)

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377302783
Basic UDI-DI: 697049309W01030000024A4
Reference: XQ-0061-02
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Diluent

D-80DR(M)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377302738
Basic UDI-DI: 697049309W01030000027AA
Reference: XQ-0060-05
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

LYK-1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301311
Basic UDI-DI: 697049309W01030000016A5
Reference: 12.01.1331A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Diluent

DIL-K:20L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301304
Basic UDI-DI: 697049309W01030000017A7
Reference: 12.01.1379A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Lyse

LYC-1：1L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301298
Basic UDI-DI: 697049309W010300000119T
Reference: 12.01.1354A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Dye

D-80FD:12mL

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377300581
Basic UDI-DI: 697049309W010300000039U
Reference: 12.01.1989A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Diluent

D-80DIL:10L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377300574
Basic UDI-DI: 697049309W010300000019Q
Reference: 12.01.1909A
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:26

Manufacturer products Authorised representative products Authorised representative actors View details