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EUDAMED Device Search

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

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23.09.2026 20:19

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494 device results listed.

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D-Dimer Turbidimetric

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873304009
Basic UDI-DI: B-84352873304009
Reference: 3145005
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:32

Manufacturer products View details

D-697994388Ir08742DM

D-Dimer Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir08742DM
Basic UDI-DI: B-697994388Ir08742DM
Reference: Ir087
EMDN: W0103020501
EMDN description: A2-ANTIPLASMIN
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

DIM-W21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120101684
Basic UDI-DI: B-697177120101684
Reference: DIM-F21(25PCS)
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

D-Dimer Turbi Latex

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182719012
Basic UDI-DI: B-62230182719012
Reference: D-856 001
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 004

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019918
Basic UDI-DI: B-62230041019918
Reference: 585 004
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 003

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019840
Basic UDI-DI: B-62230041019840
Reference: 585 003
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 002-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019772
Basic UDI-DI: B-62230041019772
Reference: 585 002-1
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019604
Basic UDI-DI: B-62230041019604
Reference: 585 002
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Turbi Latex

585 001-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041019536
Basic UDI-DI: B-62230041019536
Reference: 585 001-1
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-91AP
Basic UDI-DI: B-6-91AP
Reference: "REF: USIA00000162M, USIA00000163M"
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:14

Manufacturer products Authorised representative products Authorised representative actors View details

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064215
Basic UDI-DI: 69703416803205103J6
Reference: 0320510201
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer STAT (eCLIA)

50T，2×50T，100T，2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063027
Basic UDI-DI: 69703416803205040J7
Reference: 0320500302
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003803
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

PATHFAST D-Dimer

PATHFAST D-Dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301513
Basic UDI-DI: 4987595PF1051KXE
Reference: 30151
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7005 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

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

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003810
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996032568
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRLH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996053716
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10LH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996075381
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10HG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996093576
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRHG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

INNOVANCE D-Dimer 2.0

IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_2

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414634029
Basic UDI-DI: 0405686902242VB
Reference: 10873803
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details