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INNOVANCE Apixaban Standards

IVDR_27_MAR EB_C_INN_Riva_Stand

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414240329
Basic UDI-DI: 0405686902002UM
Reference: 10873673
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:33

Manufacturer products View details

INNOVANCE Apixaban Controls

IVDR_27_MAR EB_C_INN_Riva_Cons

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414240312
Basic UDI-DI: 0405686902003UP
Reference: 10873672
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:33

Manufacturer products View details

IMMULITE 2000 D-Dimer

IVDR_67_LLB_DUB-C_C_KIT_D-Dimer

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961255
Basic UDI-DI: 0405686901446VN
Reference: 10381041
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Protein C Reagent

IVDR_27_MAR EB_C_KIT _ProC_Reag

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640655
Basic UDI-DI: 0405686900989WS
Reference: 10873871
EMDN: W0103020611
EMDN description: PRO C GLOBAL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:24

Manufacturer products View details

ProC Control Plasma

IVDR_27_MAR EB_C_REAG_ProC_Con

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640617
Basic UDI-DI: 0405686900988WQ
Reference: 10873864
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:24

Manufacturer products View details

vWF Ag

IVDR_27_MAR EB_B_KIT _vWF_Ag

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640433
Basic UDI-DI: 0405686900991WD
Reference: 10873845
EMDN: W0103020215
EMDN description: COAGULATION FACTOR VON WILLEBRAND (AG)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:24

Manufacturer products View details

ProC Ac R

IVDR_27_MAR EB_C_KIT_ProC_Ac_R

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640174
Basic UDI-DI: 0405686900987WN
Reference: 10873848
EMDN: W0103020611
EMDN description: PRO C GLOBAL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:24

Manufacturer products View details

Test Thrombin Reagent

IVDR_27_MAR EB_C_KIT _Test_Thromb

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639635
Basic UDI-DI: 0405686900990WB
Reference: 10873894
EMDN: W0103020103
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:24

Manufacturer products View details

INNOVANCE PFA P2Y

IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768023859
Basic UDI-DI: 0405686900938W9
Reference: 10445700
EMDN: W0103020407
EMDN description: P2Y12 RECEPTOR
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

Enzygnost TAT micro

IVDR_27_MAR EB_C_KIT_Enz_TAT_mic

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768013065
Basic UDI-DI: 0405686900931VT
Reference: 10446632
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

BC Thrombin Reagent

IVDR_27_MAR EB_C_KIT_BC_Thromb

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768013102
Basic UDI-DI: 0405686900900VG
Reference: 10446636
EMDN: W0103020103
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

N Antiserum to Human Plasminogen

IVDR_27_MAR EB_B_REAG_N_AS_Plasm

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009952
Basic UDI-DI: 0405686900949WE
Reference: 10446314
EMDN: W0103020505
EMDN description: PLASMINOGEN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

N Antiserum to Human Fibrinogen

IVDR_27_MAR EB_C_REAG_N_AS_FIB

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009945
Basic UDI-DI: 0405686900943W2
Reference: 10446313
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

N Antiserum to Human Antithrombin III

IVDR_27_MAR EB_C_REAG _N_AS_ATIII

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009914
Basic UDI-DI: 0405686900939WB
Reference: 10446310
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

Manufacturer products View details

Cleaner SCS

IVDR_27_MAR EB_A_REAG_Clean_SCS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768008146
Basic UDI-DI: 0405686900857W8
Reference: 10446135
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

Imidazole Buffer Solution

IVDR_27_MAR EB_A_REAG_Imidazol

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007163
Basic UDI-DI: 0405686900869WF
Reference: 10446032
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

Enzygnost F1+2 monoclonal

IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006760
Basic UDI-DI: 0405686900930VR
Reference: 10445978
EMDN: W0103020306
EMDN description: PROTHROMBIN FRAGMENT 1 + 2
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

Dade PFA Collagen/EPI Test Cartridge

IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768003653
Basic UDI-DI: 0405686900974WD
Reference: 10445696
EMDN: W0103020401
EMDN description: AGGREGATION REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:18

Manufacturer products View details

ProC Global

IVDR_27_MAR EB_C_KIT_ProC_Glob

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640723
Basic UDI-DI: 0405686900967WG
Reference: 10873866
EMDN: W0103020611
EMDN description: PRO C GLOBAL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:15

Manufacturer products View details

LA Control Low

IVDR_27_MAR EB_B_REAG_LA_Con

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640648
Basic UDI-DI: 0405686900876WC
Reference: 10873870
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:15

Manufacturer products View details