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Dade Hepzyme

IVDR_27_MAR EB_A_PROF_REAG_Hepzyme

IVD Class AIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640396
Basic UDI-DI: 0405686900171UX
Reference: 10873841
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Dade Ci-Trol 1

IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 1

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640228
Basic UDI-DI: 0405686900168VA
Reference: 10873821
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Dade Innovin

IVDR_27_MAR EB_C_PROF_REAG_Innovin

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414640136
Basic UDI-DI: 0405686900172UZ
Reference: 10873825
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

INNOVANCE Antithrombin

IVDR_27_MAR EB_C_PROF_KIT_INN_AT

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639796
Basic UDI-DI: 0405686900173V3
Reference: 10873911
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

INNOVANCE D-Dimer Sample Diluent

IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639666
Basic UDI-DI: 0405686900176V9
Reference: 10873905
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Thromborel S

IVDR_27_MAR EB_C_PROF_REAG_Thr_S

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414639369
Basic UDI-DI: 0405686900194VB
Reference: 10873886
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Pathromtin SL

IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414635309
Basic UDI-DI: 0405686900191V5
Reference: 10873816
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

INNOVANCE D-Dimer

IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414627892
Basic UDI-DI: 0405686900174V5
Reference: 10873785
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

Standard Human Plasma

IVDR_27_MAR EB_C_PROF_REAG_SHP

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414321646
Basic UDI-DI: 0405686900193V9
Reference: 10874051
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

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: 10446672
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:02

Manufacturer products View details

HemosIL CL HIT-IgG(PF4-H)

0029706200

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 00195226001204
Basic UDI-DI: 0195226001204PZ
Reference: 0029706200
EMDN: W0103020402
EMDN description: PLATELET FACTOR 4
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 15.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Liquid Antithrombin

0020300440

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 00195226000061
Basic UDI-DI: 0195226000061PU
Reference: 0020300440
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 15.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Chromogenic Factor IX

0020001900

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

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 00195226000009
Basic UDI-DI: 0195226000009PS
Reference: 0020001900
EMDN: W0103020208
EMDN description: COAGULATION FACTOR IX
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 15.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

Thromborel S

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768030864
Basic UDI-DI: 0405686900194VB
Reference: 10484202
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 23:02

Manufacturer products View details

INNOVANCE Antithrombin

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768014826
Basic UDI-DI: 0405686900173V3
Reference: 10446015
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:58

Manufacturer products View details

Dade Innovin

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768003783
Basic UDI-DI: 0405686900172UZ
Reference: 10445704
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:58

Manufacturer products View details

Lupus Anticoagulant Confirmation Reagent (LACR)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561025161/ $$0100114XXXXXU*
Basic UDI-DI: ++G0561025163W
Reference: 102516
EMDN: W0103020606
EMDN description: LUPUS ANTICOAGULANT
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-tPAIC706-AE5H
Basic UDI-DI: B-tPAIC706-AE5H
Reference: tPAI·C706-AE10Y, tPAI·C706-AE10N, tPAI·C706-AE20Y, tPAI·C706-AE20N
EMDN: W0103020507
EMDN description: TISSUE PLASMINOGEN ACTIVATOR
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® D-Dimer Test

D-Dimer Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-351006N-05W8
Basic UDI-DI: B-nvm-351006N-05W8
Reference: 351006N-05
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Des-Gamma-Carboxy Prothrombin Test Kit (FIA)

VID136

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID136F2
Basic UDI-DI: B-VID136F2
Reference: VID136-06-011
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details