Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 01:15

Sync status

Successful

Device

3424391

Actor

47673

Certificate

3311

Filters

Show filters

Active filter:EMDN:W0103020615

11 device results listed.

Page 1 / 1

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

Manufacturer products View details

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

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

HISCL HIT IgG Assay Kit

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

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506354
Basic UDI-DI: 4987562HITIgGAssayA9
Reference: BB296616
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 28.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

HISCL HIT IgG Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506378
Basic UDI-DI: 4987562HITIgGCalDM
Reference: AR941147
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

HISCL HIT IgG Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562506361
Basic UDI-DI: 4987562HITIgGCont9L
Reference: CL306546
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Germany
Safety summary (SSCP/SSP): C028 · Rev. 3
Authorised representative: Sysmex Europe SE
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Asserachrom® HPIA - IgG

Asserachrom® HPIA - IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450006247
Basic UDI-DI: B-03607450006247
Reference: 00624
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:58

Manufacturer products View details

Asserachrom® HPIA

Asserachrom® HPIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450006155
Basic UDI-DI: B-03607450006155
Reference: 00615
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:58

Manufacturer products View details

HemosIL HIT- Ab(PF4-H) Controls

HemosIL HIT-Ab(PF4-H)

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950584940
Basic UDI-DI: 8426950584971AK
Reference: 0020013300
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:11

Manufacturer products View details

HemosIL HIT-Ab(PF4-H)

-

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

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08426950584971
Basic UDI-DI: 8426950584971AK
Reference: 0020302700
EMDN: W0103020615
EMDN description: COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:01

Manufacturer products View details