ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)

Coagulation factors

EMDN code W01030202

53 manufacturers, 288 models including 281 on the market, 17 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 53

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91036)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Quality Control：1mL×1(92031)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(707)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 26 others Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:40ml×3 R2:20ml×2（704）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（705）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（713）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（715）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（716）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（791）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（793）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（798）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:32ml×1（792）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml ×1 R2:20ml×1（703）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml×6 R2:60ml×2（795）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:90ml×1 R2:30ml×1（708）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 0.5mL×1（511001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 1.0mL×1（511002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521004）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521003）98/79	– 98/79	EUDAMED record Report an error
Stago FDA	France	Asserachrom® IX:Ag98/79 Asserachrom® VWF:CB98/79 Asserachrom® VWF:FVIIIB98/79 STA® - Deficient II98/79 STA® - Deficient IX 23 others STA® - Deficient V STA® - Deficient VII98/79 STA® - Deficient VIII STA® - Deficient X STA® - Deficient XI98/79 STA® - Fibrinogen 5 STA® - ImmunoDef II98/79 STA® - ImmunoDef IX98/79 STA® - ImmunoDef VIII STA® - ImmunoDef XI98/79 STA® - ImmunoDef XII98/79 STA® - Liatest® VWF:Ag98/79 STA® - Liquid Fib STA® - VWF:RCo98/79 sthemO Fib M sthemO II sthemO IX sthemO V sthemO VII sthemO VIII sthemO VWF Ag sthemO X sthemO XI	B IVDR, 98/79	EUDAMED record Report an error
Technoclone	Austria	Factor II immunads. Deficient Plasma98/79 Factor IX DP2 refs Factor IX immunads. Deficient Plasma98/79 Factor IX native Deficient Plasma98/79 Factor V immunads. Deficient Plasma98/79 20 others Factor VII immunads. Deficient Plasma98/79 Factor VIII DP native2 refs Factor VIII immunads. Deficient Plasma2 refs98/79 Factor X immunads. Deficient Plasma98/79 Factor X native Deficient Plasma98/79 Factor XI immunoads. Deficient Plasma98/79 Factor XI native Deficient Plasma98/79 Factor XII immunoads. Deficient Plasma98/79 Factor XII native Deficient Plasma98/79 Fibrinogen C Fibrinogen Reagent98/79 Fibrinogen Reagent Kit98/79 Fitzgerald Trait Plasma98/79 Fletcher Trait Plasma98/79 Technochrom FVIII:C 2G TECHNOCHROM FXIII98/79 Technofluor FXIII:Act TECHNOZYM vWF:Ag ELISA98/79 Technozym VWF:CBA (I)98/79 TECHNOZYM vWF:CBA ELISA98/79	C IVDR, 98/79	Website regulatory@technoclone.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy)	United States	HemosIL AcuStar VWF:Ag 0009802020 HemosIL AcuStar VWF:RCo 0009802024 HemosIL Chromogenic Factor IX 0020001900 HemosIL Factor II deficient plasma 0020012200 HemosIL Factor IX deficient plasma 0020011900 14 others HemosIL Factor V deficient plasma 0020011500 HemosIL Factor VII deficient plasma 0020011700 HemosIL Factor VIII deficient plasma 0020011800 HemosIL Factor VIII deficient plasma 0020012800 HemosIL Factor X deficient plasma 0020010000 HemosIL Factor XI deficient plasma 0020011300 HemosIL Factor XII deficient plasma 0020011200 HemosIL Factor XIII Antigen 0020201300 HemosIL Fibrinogen-C 0020301100 HemosIL Fibrinogen-C XL 0020003900 HemosIL Q.F.A. Thrombin (Bovine) 0020301700 HemosIL Q.F.A. Thrombin (Bovine) 0020301800 HemosIL von Willebrand Factor Activity 0020004700 HemosIL von Willebrand Factor Antigen 0020002300	B, C IVDR	Website Regulatory@werfen.com EUDAMED record Report an error
Sanymed	Italy	Coag Cal - Coagulazione CAL / Coagulation CAL Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl H - Coagulazione CTRL H / Coagulation CTRL H Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl N - Coagulazione CTRL N / Coagulation CTRL N Coagulation R1: 6x1ml (Lyophilized)98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) BT Line R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Bulk R1:1000mL98/79 14 others FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) MULTI-PURPOSE KIT R1:2x20mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA1500/2500 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA2000 R1:2x20mL - 140 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA3500/4500/330 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Sphera R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (RID) RID R1: 1x15 Test98/79 FIB Cal - Fibrinogeno CAL / Fibrinogen CAL MULTI-PURPOSE KIT CAL: 3x0,5mL (Lyophilized)98/79 FIB Ctrl - Fibrinogeno CTRL 2Liv. / Fibrinogen CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 2x1,5mL + CTL2: 2x0,7mL (Lyophilized)98/79 Fib-C - Fibrinogeno Clauss / Fibrinogen Clauss (Clauss) Coagulation R1:3x3mL + CAL: 1x1ml + CTRL:1x1mL + DIL: 1x9mL (Lyophilized)98/79 Im - Imidazolo / Imidazole (for Fibrinogen) Coagulation R1: 2x50ml98/79 KAO - Caolino / Kaolin (for Fibrinogen) Coagulation R1: 8x1ml98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Bulk R1:1000mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:10x5mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:4x5mL98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA	Germany	Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB BC von Willebrand Reagent IVDR_27_MAR EB_C_REAG_BC_vW2 refs Berichrom F XIII IVDR_27_MAR EB_C_KIT_Ber_FXIII2 refs Coagulation Factor II Deficient Plasma IVDR_27_MAR EB_B_REAG_FII_Def_Pl3 refs Coagulation Factor IX Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FIX_Def_Pl3 refs 13 others Coagulation Factor V Deficient Plasma IVDR_27_MAR EB_B_REAG_FV_Def_Pl3 refs Coagulation Factor VII Deficient Plasma IVDR_27_MAR EB_C_REAG_FVII_Def_Pl3 refs Coagulation Factor VIII Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FVIII_Def_Pl2 refs Coagulation Factor X Deficient Plasma IVDR_27_MAR EB_C_REAG_FX_Def_Pl3 refs Coagulation Factor XI Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXI_Def_Pl3 refs Coagulation Factor XII Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXII_Def_Pl3 refs Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 refs Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 refs Factor VIII Chromogenic Assay IVDR_27_MAR EB_C_KIT_FVIII_Chrom2 refs INNOVANCE VWF Ac IVDR_27_MAR EB_C_KIT_INN_VWF_Ac3 refs IVDR_27_MAR EB_B_KIT _vWF_Ag2 refs Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 refs N Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_N_AS_FIB	B, C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×122 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 1 test/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 10 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 15 tests/kit98/79 12 others Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 30 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 10, R2: 5.0 mL× 698/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 2.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 198/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1098/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 1 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL, VWF diluent: 1 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 2 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL, VWF diluent: 2 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 3 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL, VWF diluent: 4 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 4 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 5 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 6 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL98/79	– 98/79	regulationdept@dymind.com EUDAMED record Report an error
Tcoag FDA	Ireland	TriniCHROM Factor VIII:C TriniCLOT aPTT S 5 mL98/79 TriniCLOT Factor II98/79 TriniCLOT Factor IX98/79 TriniCLOT Factor VII98/79 6 others TriniCLOT Factor VIII98/79 TriniCLOT Factor X98/79 TriniCLOT Factor XI98/79 TriniCLOT Factor XII98/79 TriniCLOT Fibrinogen 6 mL98/79 TriniCLOT Fibrinogen Kit98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	Fibrinogen Assay MCC00501E98/79 Fibrinogen Assay MCC00502E98/79 Fibrinogen Assay MCC00513E98/79 Fibrinogen Assay MCC00514E98/79 Fibrinogen Assay MCC00515E98/79 5 others Fibrinogen Assay MCC00516E98/79 Functional Fibrinogen Assay MCT00601E98/79 Functional Fibrinogen Assay MCT00602E98/79 Functional Fibrinogen Assay MCT00603E98/79 Functional Fibrinogen Assay MCT01501E3 refs	C IVDR, 98/79	Website info@medcaptain.com EUDAMED record Report an error
Sclavo	Italy	FATTOE I PLASMA IMMUNODEPLETO K2910579098/79 FATTORE PLASMA IMMUNODEPLETO K2910579798/79 FATTORE IX PLASMA IMMUNODEPLETO K2910579498/79 FATTORE V PLASMA IMMUNODEPLETO K2910579198/79 FATTORE VII PLASMA IMMUNODEPLETO K2910579298/79 5 others FATTORE VIII PLASMA IMMUNODEPLETO K2910579398/79 FATTORE X - PLASMA IMMUNODEPLETO K2910579598/79 FATTORE XI PLASMA IMMUNODEPLETO K2910579698/79 Sclavo Fibrinogen Kit K2905376298/79 Sclavo Fibrinogen Kit K2905376598/79	– 98/79	qa@sclavo.it EUDAMED record Report an error
Biolabo	France	BE Factor II Deficient Plasma FII2 refs BE Factor IX Deficient Plasma FIX2 refs BE Factor V Deficient Plasma FV2 refs BE Factor VII Deficient Plasma FVII2 refs BE Factor VIII Deficient Plasma FVIII2 refs 4 others BE Factor X Deficient Plasma FX2 refs BE Factor XI Deficient Plasma FXI2 refs BE Factor XII Deficient Plasma FXII2 refs BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 refs	B IVDR	support@biolabo.fr EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	TEClot Factor II Deficient Plasma98/79 TEClot Factor IX Deficient Plasma98/79 TEClot Factor V Deficient Plasma98/79 TEClot Factor VII Deficient Plasma98/79 TEClot Factor VIII Deficient Plasma98/79 4 others TEClot Factor X Deficient Plasma98/79 TEClot Factor XI Deficient Plasma98/79 TEClot Factor XII Deficient Plasma98/79 TEClot FIB2 refs98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	Fibrinogen Detection Kit (Coagulation Assay)3 refs Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×10mL, OVB Buffer: 4×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×2mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×5mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×2.2mL, FIB Reconstitution fluid: 1×30mL, FIB Buffer: 1×51mL98/79 3 others Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL, Calibrator: 1×1mL98/79 R: 10×2.2mL; FIB Buffer: 1×51mL; FIB Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79	C IVDR, 98/79	EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 50mL×1, R3: 1mL×198/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 refs98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 1 other R1:8mL×5,R2:100mL×2,R3:1mL×12 refs98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
HYPHEN BioMed FDA	France	BIOPHEN™ FIX Factor IX (FIX) chromogenic3 refs BIOPHEN™ FVIII Factor VIII (FVIII) chromogenic2 refs BIOPHEN™ FVIII variant Factor VIII (FVIII) bovine2 refs FIBRIPHEN™ LRT3 refs LIAPHEN™ vWF: Ag Von Willebrand Factor Antigen (vWF: Ag)2 refs	C IVDR	Website info@hyphen-biomed.com EUDAMED record Report an error
Kamiya Biomedical FDA EU representative : Advena Limited (Malta)	United States	Coagulation Control K204C-10M3 refs K-ASSAY Factor XIII Calibrator KAI-106C98/79 K-ASSAY Factor XIII Control K135C-10M98/79 K-ASSAY Factor XIII KAI-10598/79	B IVDR, 98/79	Website info@k-assay.com EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	FIBRINOGEN 590 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00298/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	FACTOR V Assay Kit COAG128B98/79 FACTOR XI Assay Kit COAG133B98/79 Fibrinogen (L.S) Immunoturbidimetric, Multipoint BXC0442A98/79	– 98/79	Website info@fortressdiagnostics.com EUDAMED record Report an error
Hartbio FDA EU representative : Amstermed UK Ltd (Northern Ireland)	United Kingdom (ex Northern Ireland)	Hart Biologicals HB-5508-FG98/79 Hart Biologicals HB-5509-FG98/79 Hart Biologicals HB-5615-FG98/79	– 98/79	EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 FIBRINOGEN-LS Clauss Clotting Time Method2 refs98/79	– 98/79	Website EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	R1:510ml R2:330ml98/79 R1:52ml R2:330ml98/79 R1:55ml R2:330ml98/79	– 98/79	info@steellex.com EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	Fibrinogen98/79 Fibrinógeno98/79 Factor IX Deficient Plasma98/79 (no longer marketed) Factor VIII Deficient Plasma98/79 (no longer marketed)	– 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Biokit FDA	Spain	HemosIL AcuStar VWF:CB 0009802044 HemosIL VWF:RCo 0020300900	B IVDR	EUDAMED record Report an error
Erba	Czechia	Erba Thrombin Reagent 1098/79 Erba Thrombin Reagent 2098/79	– 98/79	Website EUDAMED record Report an error
Horiba FDA	France	Yumizen G FIB 2 130003638398/79 Yumizen G FIB 5 130003638498/79	– 98/79	EUDAMED record Report an error
Linear FDA	Spain	Cromatest98/79 Fibrinogen98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Nordic Biomarker	Sweden	MRX Fib Clauss98/79 MRX Green vWF Antigen98/79	– 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
r2 Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	NoFact IX98/79 NoFact VIII98/79	– 98/79	Website qa@r2diagnostics.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	Fibrinogen Reagent Kit (Clotting) W48298/79 Thrombin Time Reagent Kit (Clotting) W48498/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 refs	C IVDR, 98/79	PMS@zy-ivd.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruHemo98/79	– 98/79	EUDAMED record Report an error
bioMérieux FDA	France	VIDAS® vWF98/79	– 98/79	EUDAMED record Report an error
Biosystems FDA	Spain	FIBRINOGEN3 refs98/79	– 98/79	Website EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina	Italy	Fibrinogen‐ONE I021798/79	– 98/79	Website EUDAMED record Report an error
Chronolab	Spain	Fibrinogen, R1 8 x 2 mL, R2 1 x 100 mL, R3 1 x 3.5 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Diagnostics	Belgium	Fibrinogen HC0030098/79	– 98/79	Website EUDAMED record Report an error
Fisher Diagnostics A division of Fisher Scientific EU representative : B·R·A·H·M·S GmbH (Germany)	United States	100607, J10060798/79	– 98/79	Website EUDAMED record Report an error
Human	Germany	HemoStat Fibrinogen98/79	– 98/79	Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	Fibrinogen-LS Clauss Clotting Time Method98/79	– 98/79	EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fibrinogen (Fib)4 refs98/79	– 98/79	Website EUDAMED record Report an error
Medical & Biological Laboratories EU representative : QbD RepS BV (Belgium)	Japan	HEXAMATE Factor XIII	B IVDR	EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Fibrinogen Kit (Immunoturbidimetric Method) 60ml（R1:1×45ml+R2:1×15ml）98/79	– 98/79	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Fibrinogen (FIB) Assay Kit (Clotting Method) 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-003 refs	C IVDR	Website EUDAMED record Report an error
Precision BioLogic FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	CRYOcheck19 refs	C IVDR	EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	FIBRINÓGENO98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi Fibrinogen (Clotting Assay)10 refs98/79	– 98/79	Website EUDAMED record Report an error
Spinreact	Spain	FIBRINOGEN2 refs98/79	– 98/79	Website EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium)	China	Thrombin Reagent (for Fbg assay) Coagulation Analyzer3 refs98/79	– 98/79	EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain)	China	Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Reagent 1：5×5 mL Reagent 2：5×5 mL Dilution：2×5 mL98/79 (no longer marketed) Reagent：5×5 mL Buffer：5×10 mL98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	Egypt	Fibrinogen Fib-M-050198/79 (no longer marketed)	– 98/79	Website info@nsbiotec.com EUDAMED record Report an error
Rossix FDA No model still on the market	Sweden	Rox Factor IX98/79 (no longer marketed)	– 98/79	Website info@rossix.com EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	Fibrinogen 20 Tests - 3040198/79 (no longer marketed)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 8

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
George King Bio-Medical, Inc.	United States	George King Factor VIII Deficient Plasma George King Factor XI Deficient Plasma George King Factor X Deficient Plasma George King Factor IX Deficient Plasma George King Factor V Deficient Plasma George King Factor VII Deficient Plasma	K945857 (1995)
Fisher Diagnostics	United States	Thermo Scientific Pacific Hemostasis®	registered
Helena Laboratories	United States	Helena Fibrinogen Calibrator Helena Thrombin Reagent Fibrinogen Assay Kit	K841020 (1984)
Bio/Data Corp. Present in Europe in other categories	United States	Calcium Chloride	K812108 (1981)
Diapharma Group, Inc.	United States	–	K040362 (2004)
NASKA Co., Ltd.	Japan	–	registered
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories	United States	–	registered
Thermo Fisher Scientific Present in Europe in other categories	United States	–	registered

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