Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Haemostasis calibrators/controls

Haemostasis controls - other

EMDN code W0103020799

19 manufacturers, 82 models including 81 on the market, 8 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 19

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
Dymind EU representative : Eunitor GmbH (Germany)	China	Coagulation Comprehensive Control CTRL-COM Coag Specification 1：1 × 0.5 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 2：1 × 0.5 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 3：10 × 0.5 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 4：10 × 0.5 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 5：1 × 1.0 mL (low-level)98/79 19 others Coagulation Comprehensive Control CTRL-COM Coag Specification 6：1 × 1.0 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 7：10 × 1.0 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 8：10 × 1.0 mL (high-level)98/79 Dymind CAL-PT ,Calibrator 1:1×1.0 mL；Calibrator 2:1×1.0 mL；Calibrator 3:1×1.0 mL；Calibrator 4:1×1.0 mL；Calibrator 5:1×1.0 mL；Calibrator 6:1×1.0 mL；98/79 Heparin Calibrator CAL Anti-Xa Specification 2：Calibrator 1: 2 ×1.0 mL；Calibrator 2: 2 ×1.0 mL；Calibrator 3: 2 ×1.0 mL98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 1 ：1 × 1.0 mL (low-level)98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 2 ：1 × 1.0 mL (high-level)98/79 Protein C Calibrator CAL-PC Specification 2：6×0.5 mL/kit (reconstituted volume)98/79 Protein C Calibrator CAL-PC Specification 3：1×1.0 mL/kit (reconstituted volume)98/79 Protein C Calibrator CAL-PC Specification 4：6×1.0 mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 1 ：1×0.5mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 2 ：6×0.5mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 3 ：1×1.0 mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 4 ：6×1.0mL/kit (reconstituted volume)98/79 Unfractionated Heparin Control CTRL-UFH Specification 2 ：1 × 1.0 mL (high-level)98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 1 ：1 × 0.5 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 2 ：6 × 0.5 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 3 ：1 × 1.0 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 4 ：6 × 1.0 mL/kit98/79	– 98/79	regulationdept@dymind.com EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	D-Dimer/FDP Controls3 refs98/79 FDP Control98/79 Low Molecular Weight Heparin Controls MCH00301E98/79 Low Molecular Weight Heparin Controls MCH00304E98/79 Low Molecular Weight Heparin Controls MCH00305E98/79 11 others Plasmin-α2 Plasmin Inhibitor Complex Controls3 refs98/79 Thrombin-Anti-Thrombin III Complex Controls MCH02101E98/79 Thrombin-Anti-Thrombin III Complex Controls MCH02102E98/79 Thrombin-Anti-Thrombin III Complex Controls MCH02103E98/79 Thromboelastography Control4 refs Thromboelastography Reagent Control3 refs Thrombomodulin Controls3 refs98/79 Tissue-type Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex Controls98/79 Tissue-type Plasminogen Activator-Plasminogen Activator Inhibitor-2 Complex Controls98/79 Tissue-type Plasminogen Activator-Plasminogen Activator Inhibitor-3 Complex Controls98/79 Unfractionated Heparin Controls3 refs98/79	C IVDR, 98/79	Website info@medcaptain.com EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France)	United States	VALIDATE® D-DIMER Test Set 902il98/79 VALIDATE® D-DIMER Test Set 902st98/79 VALIDATE® FIBRINOGEN Test Set 904il98/79 VALIDATE® FIBRINOGEN Test Set 904se98/79 VALIDATE® FIBRINOGEN Test Set 904st98/79 3 others VALIDATE® HEPARIN Test Set 903il98/79 VALIDATE® HEPARIN Test Set 903se98/79 VALIDATE® HEPARIN Test Set 903st98/79	– 98/79	EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA	Germany	Dabigatran Controls IVDR_27_MAR EB_C_REAG_Dabi_Con2 refs INNOVANCE Apixaban Controls IVDR_27_MAR EB_C_INN_Riva_Cons3 refs INNOVANCE D-Dimer 2.0 CONTROL 1 IVDR_27_MAR EB_C_PROF_INN_D_Di_Con_23 refs INNOVANCE D-Dimer Controls IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con3 refs INNOVANCE Heparin LMW Control 1 IVDR_27_MAR EB_C_REAG_INN_Hep_LMW_Con3 refs 1 other INNOVANCE Heparin UF Control 1 IVDR_27_MAR EB_C_REAG_INN_Hep_UF_Con3 refs	C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CoaguDx Quality Control Level 1：1 vial×1 mL Level 2：1 vial×1 mL98/79 CoaguDx Quality Control Level 1：2 vial×1 mL Level 2：2 vial×1 mL98/79 CoaguDx Quality Control Level 1：3 vial×1 mL Level 2：3 vial×1 mL98/79 CoaguDx Quality Control Level 1：6 vial×1 mL Level 2：6 vial×1 mL98/79 Level 1: 5 x 3 mL; Level 2: 5 x 3 mL98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Linear FDA	Spain	Clonatest98/79 Clonatest D-Dimer Turbidimetric Control L-198/79 Clonatest D-Dimer Turbidimetric Control L-298/79 Cromatest2 refs98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi Coagulation Controls10 refs98/79 Hemolumi D-Dimer Controls8 refs98/79 Hemolumi FDP Controls8 refs98/79	– 98/79	Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	Boditech D-Dimer Calibrator98/79 Boditech D-Dimer Control98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Haemonetics FDA EU representative : Haemonetics Italia s.r.l (Italy)	Switzerland	TEG 6s QC Level 1 TEG 6s QC Level 2	A IVDR	regulatoryeurope@haemonetics.com EUDAMED record Report an error
Nordic Biomarker	Sweden	MRX FDP Clear High Control98/79 MRX FDP Clear Low Control98/79	– 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
Stago FDA	France	STA® - D-Di Control sthemO DDi QC 1&2	C IVDR	EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	1.0 mL/ vial, 4 vials98/79	– 98/79	EUDAMED record Report an error
Genrui Biotech FDA EU representative : Medunion S.L. (Spain)	China	D-Dimer Quality Control98/79	– 98/79	Website service@genrui-bio.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Control For D-Dimer 005Z98/79	– 98/79	Website EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	D-Dimer & FDP Control4 refs98/79	– 98/79	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-dimer Control MF-234	C IVDR	EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany)	China	D-Dimer(D-D) Control Kit configuration : 1.0 mL / 2.0 mL Level 1, Level 2, Level 3 components ( 1 / 2 / 3 of packaging size ) of a variety of combinations, a total of 16 specifications.98/79	– 98/79	Website service.channel@szchenna.com EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	D-dimer Control CC1028	C IVDR	Website info@szyhlo.com EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium)	China	D-Dimer Control2 refs	C IVDR	PMS@zy-ivd.com EUDAMED record Report an error

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