Manufacturer

Biolabo

FranceLegal entities : BIOLABO

First countries of placing on the market declared in EUDAMED : France, Germany, Italy, Türkiye

22 categories, 32 models including 32 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
Activated partial thromboplastin time	W0103020102	BE APTT K APTT Kaolin + CaCl23 refs BE APTT SL APTT Silica + CaCl23 refs CALCIUM CHLORIDE 0.025M CHLORURE DE CALCIUM 0,025M	A, C IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	KENZA 240ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories KENZA 240TX2 refs KENZA MAX BioChemisTry PHOTOMETER KENZA ONE - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories	A IVDR	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	BE DDTrol 1 DDimer Plasma low D-DIMER Controls3 refs BE Trol 1 Plasma Level 1 CONTROL PLASMAS with coagulation factors3 refs CONTROL PLASMA Level 1 CONTROL PLASMAS without coagulation factors3 refs	C IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	BE Cal Ref Reference Plasma2 refs BE Cal Set Calibration Plasma PT Prothrombin Time Standard Set2 refs	B, C IVDR	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	BE Clean SOLEA 1003 refs Cleaning Solution for TIA3 refs	A IVDR	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	HAEMOGLOBIN Colorimetric Method (Cyanmethemoglobin) HbA1c Standard Set	B, C IVDR	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	BE PT HI Thromboplastin high ISI Prothrombin Time (High ISI)3 refs BE PT LI Thromboplastin low ISI Prothrombin Time (Low ISI)3 refs	C IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	BE Owren Buffer2 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	KENZA 450ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories KENZA 450TX3 refs	A IVDR	EUDAMED record Report an error
Coagulation factor II ( prothrombin )	W0103020202	BE Factor II Deficient Plasma FII2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor ix	W0103020208	BE Factor IX Deficient Plasma FIX2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor v	W0103020204	BE Factor V Deficient Plasma FV2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor vii	W0103020205	BE Factor VII Deficient Plasma FVII2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor viii	W0103020207	BE Factor VIII Deficient Plasma FVIII2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor X	W0103020209	BE Factor X Deficient Plasma FX2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor xi	W0103020210	BE Factor XI Deficient Plasma FXI2 refs	B IVDR	EUDAMED record Report an error
Coagulation factor xii	W0103020211	BE Factor XII Deficient Plasma FXII2 refs	B IVDR	EUDAMED record Report an error
D-dimer	W0103020503	BE DDimer D-DIMER Turbidimetric Immunoassay3 refs	C IVDR	EUDAMED record Report an error
Embedding media (histology/cytology)	W01030704	HbA1c Control Set	C IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 refs	B IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	BIO SOLEA 2 - COAGULOMETER 2 CHANNELS, including accessories2 refs	A IVDR	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	BE TT Thrombin Time2 refs	B IVDR	EUDAMED record Report an error

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