Manufacturer

Sysmex

JapanLegal entities : SYSMEX CORPORATION

First countries of placing on the market declared in EUDAMED : Germany

Public contracts won : France 18, Italy 14, Germany 8, Spain 8, Belgium 5, Austria 3, Netherlands 1

EU representative : Sysmex Europe SE (Germany)

ra_archive@sysmex.co.jp

34 categories, 122 models including 116 on the market, 1 country

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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
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	CELLCLEAN CELLCLEAN AUTO CELLPACK2 refs CELLPACK DCL3 refs CELLPACK DFL2 refs 11 others CELLPACK DST3 refs Lysercell M Lysercell WDF3 refs Lysercell WDF II2 refs Lysercell WNR3 refs Lysercell WPC pocH-pack 65 pocH-pack 65XL STROMATOLYSER-WH SULFOLYSER3 refs STROMATOLYSER-4DL2 refs (no longer marketed)	A IVDR	EUDAMED record Report an error
Automated coagulometers	W0202020102	Automated Blood Coagulation Analyzer CA-600 series, CA-620 CA-620, CA-650, CA-6603 refs Automated Blood Coagulation Analyzer CN-3000 Automated Blood Coagulation Analyzer CN-3500 Automated Blood Coagulation Analyzer CN-6000 Automated Blood Coagulation Analyzer CN-6500 5 others Automated Blood Coagulation Analyzer CN-700 AUTOMATED BLOOD COAGULATION ANALYZER CS-1600 AUTOMATED BLOOD COAGULATION ANALYZER CS-2400 AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 AUTOMATED BLOOD COAGULATION ANALYZER CS-5100	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Automated Hematology Analyzer XN series, XN-1098/79 Automated Hematology Analyzer XN series, XN-2098/79 Automated Hematology Analyzer XN-L series, XN-33098/79 Automated Hematology Analyzer XN-L series, XN-35098/79 Automated Hematology Analyzer XN-L series, XN-43098/79 5 others Automated Hematology Analyzer XN-L series, XN-45098/79 Automated Hematology Analyzer XN-L series, XN-53098/79 Automated Hematology Analyzer XN-L series, XN-55098/79 XR-10 XR-Series Automated Hematology Analyzer98/79 XR-20 XR-Series Automated Hematology Analyzer98/79	– 98/79	EUDAMED record Report an error
Various hematology / histology / cytology instruments - hardware accessories	W02029080	Automated Tube Sorter TS-10 BT-40 Transportation Unit3 refs Connection Unit for DI-60, CF-60 CF-60, CF-702 refs Option Sampler SA-90 Reagent Unit RU-20 5 others Reservoir Tank RR-10 RR-10, RR-10(W/O DCL)2 refs Reservoir tank RR-20 SA-01 Sampler Unit3 refs SP sampler unit SA-02 TS-01 Automated Tube Sorter	A IVDR	EUDAMED record Report an error
Multilevel blood controls	W0103010503	EIGHTCHECK-3WP-H2 refs98/79 EIGHTCHECK-3WP-L2 refs98/79 EIGHTCHECK-3WP-N2 refs98/79 SCS-100098/79 XN CHECK6 refs98/79 2 others XN CHECK BF2 refs98/79 XN-L CHECK3 refs98/79	– 98/79	EUDAMED record Report an error
Complete cell count	W0103010103	CyLyse LV Fluorocell M Fluorocell PLT Fluorocell WDF3 refs Fluorocell WNR 3 others Fluorocell WPC STROMATOLYSER-4DS2 refs (no longer marketed) STROMATOLYSER-FB (no longer marketed)	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	CUVETTE, SUC-400A HISCL Cuvette (CN Series) REACTION TUBE, SU-40 SAMPLE PLATE, SAP-400A SB Cuvette 1 other SB Cuvette II	A IVDR	EUDAMED record Report an error
Automated urine analysers - hardware accessories	W020101020180	SA-52 Sampler Unit SA-53 Sampler Unit UF Sampler Unit, SA-51 Urine Sample Decapper Unit TH-11 Urine Sample Transportation Unit CV-113 refs	A IVDR	EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other	W0103020999	CA CAL S CA CLEAN I CA CLEAN II3 refs CN-COAGWASHER2 refs HISCL Diluent 4	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Automated Hematology Analyzer XP series, XP-30098/79 AUTOMATED HEMATOLOGY ANALYZER, pocH-100i98/79 XQ-320 XQ-Series Automated Hematology Analyzer98/79 XQ-520 XQ-Series Automated Hematology Analyzer98/79	– 98/79	EUDAMED record Report an error
Automated urine analysers	W020101020103	Fully Automated Urine Chemistry Analyzer UC-350098/79 Fully Automated Urine Particle Analyzer UF-400098/79 Fully Automated Urine Particle Analyzer UF-500098/79 UF-1500 Fully Automated Urine Particle Analyzer98/79	– 98/79	EUDAMED record Report an error
Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)	W0103020615	HISCL HIT IgG Assay Kit HISCL HIT IgG Calibrator HISCL HIT IgG Control	C IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables	W02050185	Detection Cell PIPETTE TIP RD Sample Vial	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	HISCL Cuvette L HISCL DISPOSABLE TIP STROMATOLYSER-3WP2 refs (no longer marketed)	A IVDR	EUDAMED record Report an error
Cytoflowmeters - IVD medical device software	W0202040192	CyFlow WA XF-1600 TBNK SW	A IVDR	EUDAMED record Report an error
Digital laboratory microscopes	W0202050304	Automated Hematology Slide Preparation Unit SP-50 Fully Automated Urine Particle Digital Imaging Device UD-10	A IVDR	EUDAMED record Report an error
Reagents for flow cytometry - other	W0103080699	CyFlow CLEAN CyFlow SHEATH2 refs	A IVDR	EUDAMED record Report an error
Urine strip readers	W020101020101	Semi-Automated Urine Chemistry Analyzer UC-1000 UC-1100 Semi-Automated Urine Chemistry Analyzer	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - hardware accessories	W02079080	Pneumatic Unit PU-13 Pneumatic Unit PU-17	A IVDR	EUDAMED record Report an error
Whole blood calibrators	W0103010507	XN CAL98/79 XN CAL PF98/79	– 98/79	EUDAMED record Report an error
Haematology controls - other	W0103010599	XN CHECK3 refs98/79 e-CHECK(XS)3 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Specific reticulocyte reagents	W0103010102	Fluorocell RET2 refs RET-SEARCH(II) (no longer marketed)	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - hardware accessories	W0201020180	Line Washing Solution Supply Unit LU-10	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automated Immunoassay System HISCL-800	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automated Immunoassay System HISCL-5000	A IVDR	EUDAMED record Report an error
Automated urine analysers - IVD medical device software	W020101020192	Urinalysis Work Area Information Management System U-WAM	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - IVD medical device software	W0202010192	Automated Hematology Analyzer XN series Blood Bank mode98/79	– 98/79	EUDAMED record Report an error
Cell counting instruments - other	W02020199	Automated Hematology Analyzer XN-3198/79	– 98/79	EUDAMED record Report an error
Cytoflowmeters - moderate routine	W0202040102	Flow Cytometer XF-1600	A IVDR	EUDAMED record Report an error
Devices for samples transport - other accessories	W050280	TA-01 Automated Tube Archiver	A IVDR	EUDAMED record Report an error
Flow cytometry instruments - other	W02020499	Sample Preparation System PS-10	A IVDR	EUDAMED record Report an error
Genic expression monitoring systems	W02050112	Gene Amplification Detector RD-210	A IVDR	EUDAMED record Report an error
Homogenizers	W02070403	Pretreatment System RP-10	A IVDR	EUDAMED record Report an error
Platelet controls	W0103010505	Platelet CHECK2 refs98/79	– 98/79	EUDAMED record Report an error

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