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06950996032568

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996032568
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRLH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

06950996053716

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996053716
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10LH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

06950996075381

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996075381
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10HG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

06950996093576

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996093576
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRHG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

Washing Solution for Coagulation Analyzers

IVDR_27_MAR EB_A_REAG_Wash_Sol_Coag_Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768017742
Basic UDI-DI: 0405686902053V6
Reference: 10446684
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:38

Manufacturer products View details

Dade PFA Trigger Solution

IVDR_27_MAR EB_A_REAG_PFA_TrigSol

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768003691
Basic UDI-DI: 0405686902013US
Reference: 10445701
EMDN: W0103020499
EMDN description: PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:37

Manufacturer products View details

Heterophilic Blocking Solution

IVDR_27_MAR_EB_A_PROF_MICROB_ANIM_Hetero_Block_Sol

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414645575
Basic UDI-DI: 0405686902320V6
Reference: 10874071
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:37

Manufacturer products View details

INNOVANCE D-Dimer 2.0 Control 3

IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_2

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414634234
Basic UDI-DI: 0405686902243VD
Reference: 10873806
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

INNOVANCE D-Dimer 2.0 Diluent

IVDR_27_MAR EB_a_PROF_INN_D_Di_Sam_Dil_2

IVD Class AIVDR 2017/746On the marketMicrobial substancesReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414634210
Basic UDI-DI: 0405686902244VF
Reference: 10873807
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

INNOVANCE D-Dimer 2.0

IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_2

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414634029
Basic UDI-DI: 0405686902242VB
Reference: 10873803
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

INNOVANCE Anti-Xa

IVDR_27_MAR EB_C_KIT_INN_A-Xa

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414240404
Basic UDI-DI: 0405686902001UK
Reference: 10873681
EMDN: W0103020303
EMDN description: STANDARD HEPARIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:33

Manufacturer products View details

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