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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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RAMP Total b-hCG Controls Level 2

RAMP Total b-hCG Controls - Level 2 (C4003-2)

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005282
Basic UDI-DI: B-10627966005282
Reference: C4003-2
EMDN: W010302080502
EMDN description: HAEMOSTASIS STANDARDS AND CALIBRATORS RT & POC
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 11.07.2026 02:21

Manufacturer products Authorised representative products Authorised representative actors View details

FREND D-Dimer

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540641
Basic UDI-DI: B-08809317540641
Reference: FRDD 025
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Hungary
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: IQ Products BV
Manufacturer SRN: NL-MF-000010812
UDI-DI: 08719327450918
Basic UDI-DI: B-08719327450918
Reference: IQP-396
EMDN: W0103020499
EMDN description: PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:05

Manufacturer products View details

BFS VIAL 2.5 ML

Class IIbMDDOn the marketSingle useSterile

Manufacturer: Polifarma İlaç San. ve Tic. A.Ş.
Manufacturer SRN: TR-MF-000023645
UDI-DI: 08699606437147
Basic UDI-DI: B-08699606437147
Reference: 25000396
EMDN: W0103020699
EMDN description: COAGULATION INHIBITORS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 17:56

Manufacturer products View details

RapidFor™ D-Dimer Rapid Test Kit (FIA)

VMPO08

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039335
Basic UDI-DI: B-08684595039335
Reference: VMPO08FC
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

D-DIMER Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555624307
Basic UDI-DI: B-08683555624307
Reference: B33447
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:54

Manufacturer products View details

D-DIMER Kit 40mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555622761
Basic UDI-DI: B-08683555622761
Reference: B27448
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:54

Manufacturer products View details

D-DIMER Kit 82mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555619617
Basic UDI-DI: B-08683555619617
Reference: B35447
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:51

Manufacturer products View details

D-Dimer Kit 52mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555613875
Basic UDI-DI: B-08683555613875
Reference: B24445
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:34

Manufacturer products View details

D-Dimer 77 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555611154
Basic UDI-DI: B-08683555611154
Reference: B21447
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:27

Manufacturer products View details

RapidFor™ D-Dimer Rapid Test Kit

VMD56

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941629
Basic UDI-DI: B-08683347941629
Reference: VMD56
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:05

Manufacturer products View details

RapidFor™ D-Dimer Rapid Test Kit (FIA)

VMPO08

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941025
Basic UDI-DI: B-08683347941025
Reference: VMPO08
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:03

Manufacturer products View details

Fibrinogen Reagent Kit

Fibrinogen Reagent Kit

IVD generalIVDDOn the market

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301138
Basic UDI-DI: B-08680952301138
Reference: .
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 12:28

Manufacturer products View details

APTT Activated Partial Thromboplastin Time Reagent Kit

APTT Activated Partial Thromboplastin Time Reagent Kit

IVD generalIVDDOn the market

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301121
Basic UDI-DI: B-08680952301121
Reference: .
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 12:28

Manufacturer products View details

PT-HS Prothrombin Time High Sensitivity Reagent Kit

PT-HS Prothrombin Time High Sensitivity Reagent Kit

IVD generalIVDDOn the market

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301114
Basic UDI-DI: B-08680952301114
Reference: .
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 12:28

Manufacturer products View details

Genvinset® PAI-1 4G/5G 96 tests

Genvinset® PAI-1 4G/5G

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942857
Basic UDI-DI: B-08437016942857
Reference: GVS-PAI-96
EMDN: W0103020299
EMDN description: COAGULATION FACTORS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® PAI-1 4G/5G 48 tests

Genvinset® PAI-1 4G/5G

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942598
Basic UDI-DI: B-08437016942598
Reference: GVS-PAI-48
EMDN: W0103020299
EMDN description: COAGULATION FACTORS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Genvinset® PAI-1 4G/5G 24 tests

Genvinset® PAI-1 4G/5G

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Blackhills Diagnostic Resources S.L.U.
Manufacturer SRN: ES-MF-000001091
UDI-DI: 08437016942581
Basic UDI-DI: B-08437016942581
Reference: GVS-PAI-24
EMDN: W0103020299
EMDN description: COAGULATION FACTORS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:55

Manufacturer products View details

Coagulation control P, 4 x 1 mL

Coagulation control P, 4 x 1 mL

IVD generalIVDDOn the marketHuman tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360388698699MP
Basic UDI-DI: B-084360388698699MP
Reference: 104-0023
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:33

Manufacturer products View details

Coagulation control N, 4 x 1 mL

Coagulation control N, 4 x 1 mL

IVD generalIVDDOn the marketHuman tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360388688682LT
Basic UDI-DI: B-084360388688682LT
Reference: 104-0022
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:33

Manufacturer products View details