Manufacturer

HYPHEN BioMed

France

Markets : France · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 6 · class I, II · latest in 2007 · see on the FDA website

14 categories, 42 models including 42 on the market, 1 country

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

Category	EMDN code	Registered models	Class	Contact
Control plasma for haemostasis	W0103020702	BIOPHEN™ Abnormal Control Plasma3 refs BIOPHEN™ Apixaban Control3 refs BIOPHEN™ Arixtra® Control Plasma Fondaparinux Control2 refs BIOPHEN™ Edoxaban Control3 refs BIOPHEN™ LMWH Control C33 refs 4 others BIOPHEN™ Normal Control Plasma Control Normal Plasma3 refs BIOPHEN™ Orgaran® Control Danaparoid Control2 refs BIOPHEN™ Rivaroxaban Control Low3 refs BIOPHEN™ UFH Control C13 refs	C IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	BIOPHEN™ Apixaban Calibrator3 refs BIOPHEN™ Arixtra® Calibrator Fondaparinux Calibrator2 refs BIOPHEN™ Edoxaban Calibrator3 refs BIOPHEN™ Heparin Calibrator2 refs BIOPHEN™ Orgaran® Calibrator Danaparoid Calibrator2 refs 2 others BIOPHEN™ Rivaroxaban Calibrator Low3 refs BIOPHEN™ UFH Calibrator	C IVDR	EUDAMED record Report an error
Aggregation reagents	W0103020401	Platelet Aggregation -ADP AG001K2 refs Platelet Aggregation -Arachidonic Acid2 refs Platelet Aggregation -Collagen AG005K2 refs Platelet Aggregation -Epinephrine2 refs Platelet Aggregation -Ristocetin AG004K2 refs	C IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	Hemostasis Hepes Buffer2 refs Imidazole buffer3 refs Isotonic Sample Diluent3 refs Special Tris-BSA buffer Tris-NaCl-EDTA buffer, pH 7.85	A IVDR	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	CEPHEN™ aPTT2 refs CEPHEN™ LS aPTT Lupus Sensitive	C IVDR	EUDAMED record Report an error
Anti xa activity for heparin and doac	W0103020309	BIOPHEN™ DiXaI Direct Factor Xa inhibitors (DiXaIs) BIOPHEN™ Heparin LRT Factor Xa (FXa) inhibitors3 refs	C IVDR	EUDAMED record Report an error
Calcium chloride	W0103020901	Calcium Chloride 0.025M3 refs Special Calcium Chloride Calcium chloride Heparin neutralizing	A IVDR	EUDAMED record Report an error
Coagulation factor viii	W0103020207	BIOPHEN™ FVIII Factor VIII (FVIII) chromogenic2 refs BIOPHEN™ FVIII variant Factor VIII (FVIII) bovine2 refs	C IVDR	EUDAMED record Report an error
Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)	W0103020615	ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG2 refs ZYMUTEST™ HIA (Heparin Induced Antibodies) IgGAM2 refs	C IVDR	EUDAMED record Report an error
Protein c	W0103020607	BIOPHEN™ Protein C LRT Protein C chromogenic LRT BIOPHEN™ Protein C Protein C chromogenic	C IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	BIOPHEN™ AT anti-(h)-Xa LRT Antithrombin (AT) activity - AntiXa3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor ix	W0103020208	BIOPHEN™ FIX Factor IX (FIX) chromogenic3 refs	C IVDR	EUDAMED record Report an error
Coagulation factor von willebrand (ag)	W0103020215	LIAPHEN™ vWF: Ag Von Willebrand Factor Antigen (vWF: Ag)2 refs	C IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	FIBRIPHEN™ LRT3 refs	C IVDR	EUDAMED record Report an error

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