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

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54 device results listed.

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sthemO Owren PT

PT Owren

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320585
Basic UDI-DI: 7350060320036Q
Reference: 01676
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 17.07.2026 05:44

Manufacturer products View details

STA® - Owren PT

PT Owren

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320578
Basic UDI-DI: 7350060320036Q
Reference: 01675
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:45

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MRX Antithrombin

Antithrombin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320561
Basic UDI-DI: B-27350060320561
Reference: K5033
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Red Free Protein S

Red Free Protein S

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320790
Basic UDI-DI: B-27350060320790
Reference: K5009
EMDN: W0103020612
EMDN description: FREE PROTEIN S ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX vWF Antigen Calibrator

vWF Antigen Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320394
Basic UDI-DI: B-27350060320394
Reference: K5053
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Protein C Calibrator

Protein C Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320387
Basic UDI-DI: B-27350060320387
Reference: K5023
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX FDP Clear Calibrator Set

FDP Clear Calibrator Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320356
Basic UDI-DI: B-27350060320356
Reference: K5017
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Free Protein S Calibrator

Free Protein S Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320349
Basic UDI-DI: B-27350060320349
Reference: K5044
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX PT Quick (INR) Calibrator Set

PT Quick (INR) Calibrator Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320332
Basic UDI-DI: B-27350060320332
Reference: K5043
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Fib Clauss Calibrator

Fib Clauss Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320325
Basic UDI-DI: B-27350060320325
Reference: K5042
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX Antithrombin Calibrator

Antithrombin Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320318
Basic UDI-DI: B-27350060320318
Reference: K5041
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX FDP Clear High Control

FDP Clear High Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320301
Basic UDI-DI: B-27350060320301
Reference: K5019
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX FDP Clear Low Control

FDP Clear Low Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320295
Basic UDI-DI: B-27350060320295
Reference: K5018
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX Green FDP

Green FDP

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320240
Basic UDI-DI: B-27350060320240
Reference: K5016
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Green vWF Antigen

Green vWF Antigen

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320202
Basic UDI-DI: B-27350060320202
Reference: K5052
EMDN: W0103020215
EMDN description: COAGULATION FACTOR VON WILLEBRAND (AG)
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Protein C

Protein C

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320233
Basic UDI-DI: B-27350060320233
Reference: K5020
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

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MRX Blue Free Protein S

Blue Free Protein S

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320226
Basic UDI-DI: B-27350060320226
Reference: K5010
EMDN: W0103020612
EMDN description: FREE PROTEIN S ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX Red Free Protein S

Red Free Protein S

IVD generalIVDDNo longer on the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320219
Basic UDI-DI: B-27350060320219
Reference: K5009
EMDN: W0103020612
EMDN description: FREE PROTEIN S ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX Fib Clauss

Fib Clauss

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320141
Basic UDI-DI: B-27350060320141
Reference: K5031
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX PT Quick

PT Quick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320103
Basic UDI-DI: B-27350060320103
Reference: K5024
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details