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

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01.08.2026 13:11

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426 device results listed.

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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

06950996003810

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

06950996032568

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

06950996053716

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

06950996075381

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

06950996093576

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

IMMULITE 2000 D-Dimer

IVDR_67_LLB_DUB-C_C_KIT_D-Dimer

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961255
Basic UDI-DI: 0405686901446VN
Reference: 10381041
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

N Antiserum to Human Plasminogen

IVDR_27_MAR EB_B_REAG_N_AS_Plasm

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009952
Basic UDI-DI: 0405686900949WE
Reference: 10446314
EMDN: W0103020505
EMDN description: PLASMINOGEN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

Berichrom Plasminogen

IVDR_27_MAR EB_B_KIT_Ber_Plasm

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639352
Basic UDI-DI: 0405686900904VQ
Reference: 10873885
EMDN: W0103020505
EMDN description: PLASMINOGEN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:14

Manufacturer products View details

Berichrom a2-Antiplasmin

IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414321592
Basic UDI-DI: 0405686900905VS
Reference: 10874046
EMDN: W0103020501
EMDN description: A2-ANTIPLASMIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:13

Manufacturer products View details

INNOVANCE D-Dimer Sample Diluent

IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639666
Basic UDI-DI: 0405686900176V9
Reference: 10873905
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

INNOVANCE D-Dimer

IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414627892
Basic UDI-DI: 0405686900174V5
Reference: 10873785
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-tPAIC706-AE5H
Basic UDI-DI: B-tPAIC706-AE5H
Reference: tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-2443

D-dimer Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-2443
Basic UDI-DI: B-TD-HNKX-CED-2443
Reference: /
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-R0751936

R1: 3ml x 9, R2: 3ml x3