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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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506 device results listed.

Page 19 / 26

FibroTek Fibrinogen kit

FibroTek Fibrinogen kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: r2 Diagnostics Inc.
Manufacturer SRN: US-MF-000020735
UDI-DI: 00859394006040
Basic UDI-DI: B-00859394006040
Reference: 70-410
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 11:43

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® FIBRINOGEN Test Set

904se

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005142
Basic UDI-DI: B-00859110005142
Reference: 904se
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HEPARIN Test Set

903se

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005111
Basic UDI-DI: B-00859110005111
Reference: 903se
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® FIBRINOGEN Test Set

904st

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005135
Basic UDI-DI: B-00859110005135
Reference: 904st
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® FIBRINOGEN Test Set

904il

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005128
Basic UDI-DI: B-00859110005128
Reference: 904il
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HEPARIN Test Set

903st

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005104
Basic UDI-DI: B-00859110005104
Reference: 903st
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® HEPARIN Test Set

903il

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005098
Basic UDI-DI: B-00859110005098
Reference: 903il
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® D-DIMER Test Set

902st

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005074
Basic UDI-DI: B-00859110005074
Reference: 902st
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® D-DIMER Test Set

902il

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005067
Basic UDI-DI: B-00859110005067
Reference: 902il
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

CCN-10

IVD generalIVDDOn the marketHuman tissues

Manufacturer: Precision BioLogic Inc.
Manufacturer SRN: CA-MF-000011667
UDI-DI: 00843876000015
Basic UDI-DI: B-00843876000015
Reference: CCN-10
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL CL Multi-Ab Controls

0029704000

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426951011131
Basic UDI-DI: 84269510111314D
Reference: 0029704000
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL AcuStar VWF Controls

0009802119

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950585022
Basic UDI-DI: 84269505850228Y
Reference: 0009802119
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL AcuStar HIT Controls

0009802122

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950545781
Basic UDI-DI: 842695054578197
Reference: 0009802122
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL LA Positive Control

0020012500

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950513735
Basic UDI-DI: 84269505137357H
Reference: 0020012500
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL LA Negative Control

0020012600

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950513728
Basic UDI-DI: 84269505137287L
Reference: 0020012600
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Special Test Control Level 1

0020011000

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950453062
Basic UDI-DI: 84269504530627G
Reference: 0020011000
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:04

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Homocysteine Controls

0020007900

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950453031
Basic UDI-DI: 842695045303175
Reference: 0020007900
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:04

Manufacturer products Authorised representative products Authorised representative actors View details

APC Resistance Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Pentapharm AG
Manufacturer SRN: CH-MF-000020620
UDI-DI: 07640175460105
Basic UDI-DI: 76401754608045232190QK
Reference: 08045232190
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

MRX D-dimer FEU Calibrator

D-dimer FEU Calibrator

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

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320370
Basic UDI-DI: 7350060320297A
Reference: K5045
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

MRX D-dimer DDU Calibrator

D-dimer DDU Calibrator

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

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320363
Basic UDI-DI: 73500603202878
Reference: K5012
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details