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AURYX 90 D-dimer STAT Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600670
Basic UDI-DI: B-05907514600670
Reference: I20-R0047
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:54

Manufacturer products View details

Calibrator Fibr/PT

HC00600

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101674
Basic UDI-DI: B-05404035101674
Reference: HC00600
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

Coagulation Control

HC00500

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101667
Basic UDI-DI: B-05404035101667
Reference: HC00500
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

Fibrinogen

HC00300

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101650
Basic UDI-DI: B-05404035101650
Reference: HC00300
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

PT Prothrombin Time

HC00200

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101643
Basic UDI-DI: B-05404035101643
Reference: HC00200
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

APTT (Act. Thromboplastine Time)

HC00100

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101636
Basic UDI-DI: B-05404035101636
Reference: HC00100
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

DyonDimer (D-Dimer)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200777
Basic UDI-DI: B-05200251200777
Reference: DNWA108
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

PL Chip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: ZACROS Corporation
Manufacturer SRN: JP-MF-000025159
UDI-DI: 04589448510082
Basic UDI-DI: B-04589448510082
Reference: 18002
EMDN: W0103020499
EMDN description: PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213074

AIA-PACK D-Dimer CONTROL SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213074
Basic UDI-DI: B-04560189213074
Reference: 0025432
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213067

ST AIA-PACK D-Dimer SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213067
Basic UDI-DI: B-04560189213067
Reference: 0025532
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213050

ST AIA-PACK D-Dimer CALIBRATOR SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213050
Basic UDI-DI: B-04560189213050
Reference: 0025332
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212817

ST AIA-PACK Homocysteine PRETREATMENT SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212817
Basic UDI-DI: B-04560189212817
Reference: 0025726
EMDN: W0103020614
EMDN description: HOMOCYSTEINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212800

AIA-PACK Homocysteine CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212800
Basic UDI-DI: B-04560189212800
Reference: 0025426
EMDN: W0103020614
EMDN description: HOMOCYSTEINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212794

ST AIA-PACK Homocysteine SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212794
Basic UDI-DI: B-04560189212794
Reference: 0025526
EMDN: W0103020614
EMDN description: HOMOCYSTEINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

04560189212787

ST AIA-PACK Homocysteine CALIBRATOR SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189212787
Basic UDI-DI: B-04560189212787
Reference: 0025326
EMDN: W0103020614
EMDN description: HOMOCYSTEINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

09120036864481

Technochrom Dilution Buffer

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036864481
Basic UDI-DI: 912003686TCC900000012U
Reference: 5340200
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details

09120036861503

NaCl 0.9 %

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036861503
Basic UDI-DI: 912003686TC950000001RW
Reference: 4847127
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:32

Manufacturer products View details

09120036860872

Imidazole Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860872
Basic UDI-DI: 912003686TC9J00000015V
Reference: 5410008
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:32

Manufacturer products View details

09120036860858

Citrate Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860858
Basic UDI-DI: 912003686TC9G000000144
Reference: 5400045
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:32

Manufacturer products View details

09120036860582

CaCl2 50 mM

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860582
Basic UDI-DI: 912003686TC9C0000002ZP
Reference: 5279025
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:32

Manufacturer products View details