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EUDAMED Device Search

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INNOVANCE Antithrombin

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768014826
Basic UDI-DI: 0405686900173V3
Reference: 10446015
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:58

Manufacturer products View details

Dade Innovin

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768003783
Basic UDI-DI: 0405686900172UZ
Reference: 10445704
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:58

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Lupus Anticoagulant Confirmation Reagent (LACR)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561025161/ $$0100114XXXXXU*
Basic UDI-DI: ++G0561025163W
Reference: 102516
EMDN: W0103020606
EMDN description: LUPUS ANTICOAGULANT
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors 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

NADAL® D-Dimer Test

D-Dimer Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-351006N-05W8
Basic UDI-DI: B-nvm-351006N-05W8
Reference: 351006N-05
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Des-Gamma-Carboxy Prothrombin Test Kit (FIA)

VID136

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID136F2
Basic UDI-DI: B-VID136F2
Reference: VID136-06-011
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (FIA)

VID11

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID112L
Basic UDI-DI: B-VID112L
Reference: VID11-03-011
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

TEClot TT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: TECO Medical Instruments, Production + Trading GmbH
Manufacturer SRN: DE-MF-000022642
UDI-DI: D-TT-A0401-0207P
Basic UDI-DI: B-TT-A0401-0207P
Reference: A0401-020
EMDN: W0103020103
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:24

Manufacturer products View details

TM Thrombomodulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TM706-AEBL
Basic UDI-DI: B-TM706-AEBL
Reference: TM706-AE10Y, TM706-AE10N, TM706-AE20Y, TM706-AE20N
EMDN: W0103020399
EMDN description: SPECIAL COAGULATION TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:59

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

TAT Thrombin-Antithrombin III Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-TAT706-AE6M
Basic UDI-DI: B-TAT706-AE6M
Reference: TAT706-AE10Y, TAT706-AE10N, TAT706-AE20Y, TAT706-AE20N
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

PT (INR) control kit

IVD generalIVDDOn the marketHuman tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST1800E4
Basic UDI-DI: B-ST1800E4
Reference: ST1800
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:43

Manufacturer products View details

D-Dimer control kit

IVD generalIVDDOn the marketHuman tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST1500DM
Basic UDI-DI: B-ST1500DM
Reference: ST1500
EMDN: W010302080501
EMDN description: HEMOSTASIS CONTROLS RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:43

Manufacturer products View details

PT (INR) test kit (32 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0180DJ
Basic UDI-DI: B-ST0180DJ
Reference: ST0180
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

D-Dimer test kit (6 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0151DB
Basic UDI-DI: B-ST0151DB
Reference: ST0151
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

D-Dimer test kit (16 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0150D9
Basic UDI-DI: B-ST0150D9
Reference: ST0150
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022013E7
Basic UDI-DI: B-SAC2022013E7
Reference: SAC2022013
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022015EB
Basic UDI-DI: B-SAC2022015EB
Reference: SAC2022015
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022014E9
Basic UDI-DI: B-SAC2022014E9
Reference: SAC2022014
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

BGI

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022002E2
Basic UDI-DI: B-SAC2022002E2
Reference: SAC2022002
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details