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06975237550021

R1:5*10ml R2:5*10ml

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TAIZHOU STEELLEX BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000023056
UDI-DI: 06975237550021
Basic UDI-DI: B-06975237550021
Reference: 100201
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Romania
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 30.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950163
Basic UDI-DI: B-08431673950163
Reference: 1709226
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:39

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IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792268
Basic UDI-DI: B-08431673792268
Reference: 1709225
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:39

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FIBRINOGEN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950156
Basic UDI-DI: B-08431673950156
Reference: 1709212
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:39

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IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792244
Basic UDI-DI: B-08431673792244
Reference: 1709224
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792237
Basic UDI-DI: B-08431673792237
Reference: 1709223
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

Manufacturer products View details

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792220
Basic UDI-DI: B-08431673792220
Reference: 1709222
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

Manufacturer products View details

FIBRINOGEN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792114
Basic UDI-DI: B-08431673792114
Reference: 1709211
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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APTT

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792015
Basic UDI-DI: B-08431673792015
Reference: 1709201
EMDN: W0103020102
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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COAGULATION CONTROL P

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673791063
Basic UDI-DI: B-08431673791063
Reference: 1709106
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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COAGULATION CONTROL N

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673791049
Basic UDI-DI: B-08431673791049
Reference: 1709104
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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COAGULATION CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673791018
Basic UDI-DI: B-08431673791018
Reference: 1709101
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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Clonatest

Plasma Protein Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873320047
Basic UDI-DI: B-84352873320047
Reference: CT39155
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 09:18

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Cromatest

Plasma Protein Control (N-II)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873320016
Basic UDI-DI: B-84352873320016
Reference: 3915015
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 09:18

Manufacturer products View details

Cromatest

Plasma Protein Control (N-I)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873320009
Basic UDI-DI: B-84352873320009
Reference: 3915010
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 09:18

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04987562506354

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

D-Dimer Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819714
Basic UDI-DI: B-06950334819714
Reference: 32027164
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762667
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-20
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764685
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-25
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

BIOPHEN™ Abnormal Control Plasma

Control Plasma

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008313
Basic UDI-DI: 366353700025B5
Reference: 223301
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 24.07.2026 22:55

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