Fabricant

Dirui

ChineEntités : DIRUI INDUSTRIAL CO., LTD

Premiers pays de mise sur le marché déclarés dans EUDAMED : Allemagne, Autriche, Bulgarie, Croatie, Espagne, Grèce, Italie, Pologne, Roumanie

Mandataire UE : SUNGO Europe B.V. (Pays-Bas)

42 catégories, 153 modèles dont 153 en vente, 1 pays

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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	B-Z Cleanser3 réf. BCC-3D Lyse 500mL BF-CRP Lyse 200mL BF-DS Diluent 20L BF-FBH Lyse 500mL 11 autres BF-FDO Lyse 5L BF-FDOI Lyse 500mL, 5L BF-FDT Lyse 500mL BF-FDTI Lyse 200mL, 500mL BF-LD Lyse 500mL， 1L2 réf. BF-LH Lyse 100mL， 200mL2 réf. BF-SLS-I Lyse 500mL BF-SLS-II Lyse 2L BF-WFL Lyse 4L BF-WNL Lyse 4L Lyse 500mL2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Haematology controls - other	W0103010599	Control for Automatic Hematology Analyzer (5-part) Level 1: 2.5 ml98/79 Control for Automatic Hematology Analyzer (5-part) Level 2: 2.5 ml98/79 Control for Automatic Hematology Analyzer (5-part) Level 3: 2.5 ml98/79 Control for Body Liquid Level 1: 1×3.0mL98/79 Control for Body Liquid Level 2: 1×3.0mL98/79 6 autres Control for Hematology Analyzer Level 1: 2ml98/79 Control for Hematology Analyzer Level 2: 2ml98/79 Control for Hematology Analyzer Level 3: 2ml98/79 Fluorescent Control Level 1: 1×2.5mL98/79 Fluorescent Control Level 2: 1×2.5mL98/79 Fluorescent Control Level 3: 1×2.5mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)3 réf. D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL,Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 5 autres D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Prothrombin time ( quick test )	W0103020101	Prothrombin Time Detection Kit (Coagulation Assay)6 réf. Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 5 autres Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×2.2mL, PT Reconstitution fluid: 1×30mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL, Calibrator: 1×1mL98/79 R: 10×2.2mL; PT Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79 R: 10×2.2mL; TT Reconstitution Fluid: 1×3098/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Automated urine analysers	W020101020103	Urinalysis Hybrid FUS-100098/79 Urinalysis Hybrid FUS-200098/79 Urinalysis Hybrid FUS-3000Plus98/79 Urinalysis System MUS-360098/79 Urinalysis System MUS-960098/79 4 autres Urine Analyzer H-160098/79 Urine Analyzer H-180098/79 Urine Analyzer H-80098/79 Vaginal Infections Analyzer GMD-S60098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Fibrinogen assays (factor i)	W0103020201	Fibrinogen Detection Kit (Coagulation Assay)3 réf. 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 autres 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	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Automatic Hematology Analyzer BCC-360098/79 Automatic Hematology Analyzer BCC-390098/79 Automatic Hematology Analyzer BCC-396098/79 Automatic Hematology Analyzer BF-680098/79 Automatic Hematology Analyzer BF-690098/79 2 autres Automatic Hematology Analyzer BF-6900CRP98/79 Automatic Hematology Analyzer BF-6960CRP98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - low routine (with ise mode test/h <= 400)	W0201010105	Auto-Chemistry Analyzer CS-300B98/79 Auto-Chemistry Analyzer CS-40098/79 Auto-Chemistry Analyzer CS-45098/79 Auto-Chemistry Analyzer CS-48098/79 Auto-Chemistry Analyzer CS-T18098/79 1 autre Auto-Chemistry Analyzer CS-T240Plus98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Control plasma for haemostasis	W0103020702	Coagulation Analysis Multi-Control3 réf. Coagulation Analysis Multi-Control level 1: 10×1mL98/79 Coagulation Analysis Multi-Control level 1: 1×1mL98/79 Coagulation Analysis Multi-Control level 2: 10×1mL98/79 Coagulation Analysis Multi-Control level 2: 1×1mL98/79 1 autre DIRUI High value:1×0.5mL; Low value:1×0.5mL2 réf.98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)	W0202010102	Automatic Hematology Systerm BF-720098/79 Automatic Hematology Systerm BF-7200PLus98/79 Automatic Hematology Systerm BF-760098/79 Automatic Hematology Systerm BF-7600PLus98/79 DIRUI Analytical module + sample feeder + computer2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Fibrinogen degradation products	W0103020502	Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)3 réf. Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Thrombin time / reptilase / batroxobin time	W0103020103	Thrombin Time Detection Kit (Coagulation Assay)3 réf. Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×10mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×2mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×5mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Reagent: 10×5mL, TT Reconstitution fluid: 1×51mL98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200)	W0201010107	Auto-Chemistry Analyzer CS-1300A98/79 Auto-Chemistry Analyzer CS-1300B98/79 Auto-Chemistry Analyzer CS-1400i3 réf. Auto-Chemistry Analyzer CS-160098/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Urinary sediment devices	W0201010202	DIRUI Analytical module + Pre-storage tray + Connecting bridge + Reclaiming tray + Sample feeder + Computer98/79 Urine Sediment Analyzer FUS-10098/79 Urine Sediment Analyzer FUS-36098/79 Urine Sediment Analyzer FUS-56098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Antithrombin	W0103020602	Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)3 réf. Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 2×5mL, R2: 1×2mL, R1 Reconstitution Fluid: 1×15mL, OVB Buffer: 1×51mL98/79 Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 6×5mL, R2: 3×2mL, R1 Reconstitution Fluid: 1×35mL, OVB Buffer: 1×51mL98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - moderate routine (with ise mode test/h > 400 and <= 800)	W0201010106	Auto-Chemistry Analyzer CS-120098/79 Auto-Chemistry Analyzer CS-65098/79 Auto-Chemistry Analyzer CS-68098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemostasis standards and calibrators RT & POC	W010302080502	Coagulation Analysis Multi-Calibrator3 réf. Coagulation Analysis Multi-Calibrator 10×1mL98/79 Coagulation Analysis Multi-Calibrator 1×1mL98/79	C IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 1×100 Tests/kit98/79 Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 1×50 Tests/kit98/79 Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) 2×50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mixed panel multiparameter analysers - high routine (throughput > 2000 test/h)	W0201030103	DIRUI 1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module + 1 computer & cart98/79 Integrated System CSM-80002 réf.98/79 Integrated System CSM-900098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reticulocyte controls	W0103010506	Control for Reticulocyte Level 1: 1×3.0mL98/79 Control for Reticulocyte Level 2: 1×3.0mL98/79 Control for Reticulocyte Level 3: 1×3.0mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis antibody assays total	W0105010302	Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×100 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 1×50 Tests/kit98/79 Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay) 2×50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Activated partial thromboplastin time	W0103020102	Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×2mL, Calcium Chloride Solution: 1×51mL98/79 Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×5mL, Calcium Chloride Solution: 1×51mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - high routine (with ise mode test/h > 1.200)	W0201010108	Auto-Chemistry Analyzer CS-200098/79 Auto-Chemistry Analyzer CS-2000i98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cytochemical staining reagents	W01030702	FE Dye 1. Dye A: 1×50mL/bottle; Dye B: 1× 50mL/bottle 2. Dye A: 1×100mL/bottle, Dye B: 1×100mL/bottle 3. Dye A: 1×200mL/bottle, Dye B: 1×200mL/bottle 4. Dye A: 1×400mL/bottle, Dye B: 1×400mL/bottle 5. Dye A: 1×500mL/bottle, Dye B: 1×500mL/bottle2 réf. UA Dye 100mL/bottle, 150mL/bottle2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Reagents for (automated) haematology analyzer - other	W0103010199	BF-RF Dye3 réf. DIRUI H-180098/79	A IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Whole blood calibrators	W0103010507	Calibrator for Automatic Hematology Analyzer (5-part) 2.5 mL98/79 Fluorescent Calibrator 1×3.5mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated coagulometers	W0202020102	BCA-1000 Automatic Blood Coagulation Analyzer BCA-1000 BCA-30003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - high routine (throughput > 700 test/h)	W0201020104	CM-320 Chemiluminescence Immunoassay Analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	CM-180 Chemiluminescence Immunoassay Analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	CM-320i Chemiluminescence Immunoassay Analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Automated slide stainers	W0202059002	BSP-800 Automated Hematology Smear Slide Processor2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated systems for the management of pre and post-analysis	W02060101	LA-60 Sample Processing System	A IVDR	Fiche EUDAMED Signaler une erreur
Auxiliary reagents (haemostasis) - other	W0103020999	Automatic Blood Coagulation Analyzer Detergent I3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Buffers (haemostasis)	W0103020903	Sample Diluent Blood Coagulation2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Calibration plasma for haemostasis	W0103020701	DIRUI CAL1：1×0.5mL CAL2：1×0.5mL CAL3：1×0.5mL CAL4：1×0.5mL CAL5：1×0.5mL CAL6：1×0.5mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - high routine (random access without ise mode test/h > 1.200)	W0201010104	Auto-Chemistry Analyzer CS-200098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-4803 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	CS-600B CS-650 CS-680 CS-12003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igm	W0105040304	DIRUI 1×100 test/kit R1:1×4mL R2:1×5mL R3:1×9mL Calibrator High value:1×1mL; L Calibrator Low value:1×1mL Control Level 1: 1×1mL; Control Level 2: 1×1mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 2 igg	W0105040309	DIRUI 1×100 test/kit R1:1×2mL; R2:1×2.5mL; R3:1×2.5mL Calibrator High value:1×1mL; Calibrator Low value:1×1mL Control Level 1:1×1mL Control Level 2: 1×1mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Semi-automated urine analysers	W020101020102	H-100,H-500,HC-3003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Thrombin-antithrombin III-complex	W0103020307	R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur

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