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Thrombin Time (TT) Test Kit (Coagulation)

Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303596
Basic UDI-DI: B-06936895303596
Reference: Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）
EMDN: W0103020103
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Quality control plasma (normal): 1.0mL×1（521003）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303565
Basic UDI-DI: B-06936895303565
Reference: Quality control plasma (normal): 1.0mL×1（521003）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Quality control plasma (abnormal): 1.0mL×1（521004）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303572
Basic UDI-DI: B-06936895303572
Reference: Quality control plasma (abnormal): 1.0mL×1（521004）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Quality control plasma (abnormal): 0.5mL×1（521002）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303558
Basic UDI-DI: B-06936895303558
Reference: Quality control plasma (abnormal): 0.5mL×1(521002
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Quality control plasma (normal): 0.5mL×1（521001）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303541
Basic UDI-DI: B-06936895303541
Reference: Quality control plasma (normal): 0.5mL×1（521001）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Calibration plasma: 1.0mL×1（511002）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303534
Basic UDI-DI: B-06936895303534
Reference: Calibration plasma:1.0mL×1（511002）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303510
Basic UDI-DI: B-06936895303510
Reference: Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Calibration plasma: 0.5mL×1（511001）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303527
Basic UDI-DI: B-06936895303527
Reference: Calibration plasma: 0.5mL×1（511001）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303503
Basic UDI-DI: B-06936895303503
Reference: Freeze-dried：Reagent:2.5mL×5, Diluent:50mL×2（502001）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Test Kit (Coagulation)

Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895303497
Basic UDI-DI: B-06936895303497
Reference: Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

STA® - Owren PT

PT Owren

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320578
Basic UDI-DI: 7350060320036Q
Reference: 01675
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 16.07.2026 11:45

Manufacturer products View details

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064215
Basic UDI-DI: 69703416803205103J6
Reference: 0320510201
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer STAT (eCLIA)

50T，2×50T，100T，2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063027
Basic UDI-DI: 69703416803205040J7
Reference: 0320500302
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG

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: 06950996003803
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

Cytrynian trisodowy 3,2% 500ml

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941058
Basic UDI-DI: 590649294ADPKJN
Reference: 2001.3
EMDN: W0103020902
EMDN description: CITRATE
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details

Cytrynian trisodowy 3,2% 1L

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941065
Basic UDI-DI: 590649294ADPKJN
Reference: 2001.2
EMDN: W0103020902
EMDN description: CITRATE
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details

Cytrynian trisodowy 3,8% 1L

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941072
Basic UDI-DI: 590649294ADPKJN
Reference: 2005.2
EMDN: W0103020902
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details

Cytrynian trisodowy 3,8% 500ml

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941089
Basic UDI-DI: 590649294ADPKJN
Reference: 2005.3
EMDN: W0103020902
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details

Cytrynian trisodowy 3,8% 100ml

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941096
Basic UDI-DI: 590649294ADPKJN
Reference: 2005.5
EMDN: W0103020902
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details

Wersenian dipotasowy 10% 100ml

-

IVD Class ANot specifiedOn the market

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941102
Basic UDI-DI: 590649294ADPKJN
Reference: 2002.5
EMDN: W0103020902
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:16

Manufacturer products View details