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09120036861305

TECHNOZYM Protein C ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036861305
Basic UDI-DI: B-09120036861305
Reference: TC12021
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: Austria
Authorised representative: -
Last updated: 22.09.2026 01:23

Manufacturer products View details

Berichrom Antithrombin III (A)

IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414321578
Basic UDI-DI: 0405686900140UL
Reference: 10874043
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:27

Manufacturer products View details

BIOPHEN™ Protein C LRT

Protein C chromogenic LRT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537052958
Basic UDI-DI: 366353700062BB
Reference: 221211
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

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ZYMUTEST™ HIA (Heparin Induced Antibodies) MonoStrip IgG

Heparin Induced Antibodies IgG

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046803
Basic UDI-DI: 366353700040AZ
Reference: RK041A
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

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ZYMUTEST™ HIA (Heparin Induced Antibodies) IgGAM

Heparin-Induced Antibodies - IgGAM

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537018770
Basic UDI-DI: 366353700046BD
Reference: RK040D
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

BIOPHEN™ Protein C

Protein C chromogenic

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008238
Basic UDI-DI: 366353700063BD
Reference: 221205
EMDN: W0103020607
EMDN description: PROTEIN C
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 21:04

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) MonoStrip IgGAM

Heparin-Induced Antibodies - IgGAM

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537046810
Basic UDI-DI: 366353700046BD
Reference: RK041D
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG

Heparin Induced Antibodies IgG

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537018763
Basic UDI-DI: 366353700040AZ
Reference: RK040A
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 20:28

Manufacturer products View details

Antithrombin III Assay Kit

Coagulation Analyzer

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SysCan BioTech (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000040462
UDI-DI: 06974490250600
Basic UDI-DI: B-06974490250600
Reference: Ci-AT-24
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 12.08.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

Factor VIII INH Kit native

Factor VIII Inhibitor Reagent Kit

IVD Class CIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036860377
Basic UDI-DI: 912003686TC0F0000001UX
Reference: 5152005
EMDN: W0103020603
EMDN description: COAGULATION FACTOR VIII INHIBITOR
First on market country: Austria
Authorised representative: -
Last updated: 10.08.2026 22:49

Manufacturer products View details

Factor VIII INH Kit

Factor VIII Inhibitor Reagent Kit HCV neg.

IVD Class CIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Manufacturer SRN: AT-MF-000024115
UDI-DI: 09120036862333
Basic UDI-DI: 912003686TC0F0000001UX
Reference: 5152009
EMDN: W0103020603
EMDN description: COAGULATION FACTOR VIII INHIBITOR
First on market country: Austria
Authorised representative: -
Last updated: 10.08.2026 22:49

Manufacturer products View details

AESKULISA® Ethanolamine-GM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500890
Basic UDI-DI: B-04250289500890
Reference: 3209
EMDN: W0103020601
EMDN description: ANTI-PHOSPHOLIPID ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:10

Manufacturer products View details

AESKULISA® Inositol-GM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500883
Basic UDI-DI: B-04250289500883
Reference: 3208
EMDN: W0103020601
EMDN description: ANTI-PHOSPHOLIPID ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 10.08.2026 16:10

Manufacturer products View details

Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)

R1: 2×5mL, R2: 1×2mL, R1 Reconstitution Fluid: 1×15mL, OVB Buffer: 1×51mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794517609
Basic UDI-DI: B-06925794517609
Reference: 3009956
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 07.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)

R1: 6×5mL, R2: 3×2mL, R1 Reconstitution Fluid: 1×35mL, OVB Buffer: 1×51mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794517616
Basic UDI-DI: B-06925794517616
Reference: 3009957
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 07.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

BIOPHEN™ AT anti-(h)-Xa LRT

Antithrombin (AT) activity - AntiXa

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537072253
Basic UDI-DI: 366353700053BA
Reference: 221123
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: France
Authorised representative: -
Last updated: 06.08.2026 01:42

Manufacturer products View details

Revohem™ AT LRT

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085321
Basic UDI-DI: 366353700053BA
Reference: AB751585
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

BIOPHEN™ AT anti-(h)-Xa LRT

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537072260
Basic UDI-DI: 366353700053BA
Reference: 221127
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ AT LRT NEO

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085420
Basic UDI-DI: 366353700053BA
Reference: AU701973
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details

Revohem™ AT LRT

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

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085338
Basic UDI-DI: 366353700053BA
Reference: BK685365
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:46

Manufacturer products View details