Manufacturer

Rayto

ChinaLegal entities : Rayto Life and Analytical Sciences Co., Ltd.

Markets : Germany · Iceland · Ireland

Approvals : EU – class A, B

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

Website support@rayto.com

40 categories, 198 models including 174 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
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Category	EMDN code	Registered models	Class	Contact
Automated 3 part hematology analysers	W0202010201	Auto Hematology Analyzer RT-7600 Hemaray 8198/79 Hemaray 8298/79 Hemaray 8398/79 Hemaray 8598/79 7 others Hemaray 8898/79 Hemaray 8998/79 RT-720098/79 RT-730098/79 RT-760098/79 RT-7600S98/79 RT-790098/79	B IVDR, 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Auto Hematology Analyzer Hemaray 51 Auto Hematology Analyzer Hemaray 86 Hemaray 50CRP98/79 Hemaray 5298/79 Hemaray 5398/79 7 others Hemaray 5498/79 Hemaray 55CRP98/79 Hemaray 56CRP98/79 Hemaray 57CRP98/79 Hemaray 58CRP98/79 Hemaray 59CRP98/79 Hemaray 8698/79	B IVDR, 98/79	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Auto Chemistry Analyzer Chemray 120 Auto Chemistry Analyzer Chemray 2000 Auto Chemistry Analyzer Chemray 2020 Auto Chemistry Analyzer Chemray 240 Auto Chemistry Analyzer Chemray 310 7 others Auto Chemistry Analyzer Chemray 330 Auto Chemistry Analyzer Chemray 420 Rayto RT-1904C Rayto RT-9700 Semi-auto Chemistry Analyzer RT-9000 Semi-auto Chemistry Analyzer RT-9200 Semi-auto Chemistry Analyzer RT-9500	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	100 Tests/Kit98/79 200 Tests/Kit98/79 50 Tests/Kit2 refs98/79 R1: 3ml x 9, R2: 3ml x398/79 R1: 4ml x 9, R2: 4ml x 398/79 6 others R1: 5ml x 9, R2: 5ml x 398/79 R1:30mL×1 R2:10mL×198/79 R1:30mL×2 R2:10mL×298/79 R1:3mL×6 R2:3mL×298/79 R1:9mL×3 R2:3mL×398/79 R1:9mL×6 R2:3mL×698/79	– 98/79	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Cleanser RC-1, RC-23 refs Cleanser RC-863 refs Concentrated Cleanser RC-86C2 refs Concentrated Cleanser REC3 refs Diluent for Hematology Analyzer RD-502 refs 5 others Diluent for Hematology Analyzer RD-73 refs Diluent for Hematology Analyzer RD-862 refs Lyse for Hematology Analyzer RL-50D，RL-50H3 refs Lyse for Hematology Analyzer RL-73 refs Lyse for Hematology Analyzer RL-86D，RL-86H3 refs	A IVDR	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	R1: 20ml x1, R2: 20ml x 198/79 R1: 3ml x 6, R2: 3ml x 698/79 R1: 3ml x 9, R2: 3ml x398/79 R1: 4ml x 9, R2: 4ml x 398/79 R1: 5ml x 9, R2: 5ml x 398/79 5 others R1:30mL×1 R2:10mL×198/79 R1:30mL×2 R2:10mL×298/79 R1:3mL×6 R2:3mL×298/79 R1:9mL×3 R2:3mL×398/79 R1:9mL×6 R2:3mL×698/79	– 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	10mL×1098/79 2mL×1098/79 5mL×1098/79 R1: 10 mL×10, R2: 120 mL×198/79 R1: 1mL×10, R2: 15mL×198/79 5 others R1: 1mL×5, R2: 15mL×198/79 R1:10mL×10，R2:60mL×298/79 R1:2ml×10,R2:30ml×198/79 R1:4ml×10,R2:50ml×198/79 R1:5mL×10，R2:60mL×198/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	R1: 10mL×10, R2: 120mL×198/79 R1: 1mL×10, R2: 15mL×198/79 R1: 1mL×5, R2: 15mL×198/79 R1:10mL×10，R2:60mL×298/79 R1:2ml×10,R2:30ml×198/79 2 others R1:4ml×10,R2:50ml×198/79 R1:5mL×10，R2:60mL×198/79	– 98/79	EUDAMED record Report an error
Automated coagulometers	W0202020102	Automated Coagulation Analyzer RAC-050 Automated Coagulation Analyzer RAC-120 Automated Coagulation Analyzer RAC-130 Automated Coagulation Analyzer RAC-1800 Automated Coagulation Analyzer RAC-2800 1 other Automated Coagulation Analyzer RAC-5800	A IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 50mL×1, R3: 1mL×198/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 refs98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 1 other R1:8mL×5,R2:100mL×2,R3:1mL×12 refs98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Chemiluminescence Analyzer Lumiray 600 Chemiluminescence Analyzer Lumiray 630 Chemiluminescence Analyzer Lumiray 650 Chemiluminescence Analyzer Lumiray 670 Chemiluminescence Analyzer Lumiray 680	A IVDR	EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other	W0103020999	125ml×498/79 40ml×498/79 50ml×498/79 60ml×498/79 75ml×498/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Microplate Reader RT-2100C Microplate Reader RT-6000 Microplate Reader RT-6100 Microplate Reader RT-6500 Microplate Reader RT-6900	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automated Specific Protein Analyzer Protray 750 Chemiluminescence Analyzer Lumiray 1200 Chemiluminescence Analyzer Lumiray 1600 Chemiluminescence Analyzer Lumiray4000	A IVDR	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit98/79 50 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Immunohistochemistry processors	W0202059001	Microplate Washer RT-2600C Microplate Washer RT-3000 Microplate Washer RT-3100 Microplate Washer RT-3500	A IVDR	EUDAMED record Report an error
Syphilis reagents other	W0105010399	100 Tests/Kit98/79 200 Tests/Kit98/79 30 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Antibody detection (immunohaematology) - other	W0103030399	100 Tests/Kit98/79 200 Tests/Kit98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	Chemiluminescence Analyzer Probe Maintenance Cleanser 70mL×42 refs Chemiluminescence Analyzer Tube Maintenance Cleanser 120mL×4 Cleanser REC-L2 refs	A IVDR	EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc	W0105900201	Folate Lysis Reagent 200Tests/Kit3 refs Sample Diluent RD-L1, RD-L23 refs Vitamin B12 Lysis Reagent 200Tests/Kit3 refs	A IVDR	EUDAMED record Report an error
Coronavirus igg	W0105041103	100 Tests/Kit98/79 200 Tests/Kit2 refs98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Auto Blot Processor Blotray 866 Auto Blot Processor Blotray 933 Auto Blot Processor Blotray 955	A IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	100 Tests/Kit98/79 200 Tests/Kit98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	Semi-auto Coagulation Analyzer RT-2201C Semi-auto Coagulation Analyzer RT-2202 Semi-auto Coagulation Analyzer RT-2204C	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	Chemiluminescence Analyzer Lumiray 4030 Chemiluminescence Analyzer Lumiray 4080	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	Auto Chemistry Analyzer Chemray 380 Auto Chemistry Analyzer Chemray 800	A IVDR	EUDAMED record Report an error
Coronavirus igm	W0105041104	100 Tests/Kit98/79 50 Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	Incubator RT-A19 Incubator Shaker RT-A29	A IVDR	EUDAMED record Report an error
Chemistry analysers - consumables	W0201010185	RBA-Cleanser RCC-12 refs	A IVDR	EUDAMED record Report an error
Coagulometers - consumables	W0202020185	RAC Cleaner RAC-12 refs	A IVDR	EUDAMED record Report an error
Cmv igg No model still on the market	W0105040203	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Cmv igm No model still on the market	W0105040204	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Rubella virus igg No model still on the market	W0105040102	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Rubella virus igm No model still on the market	W0105040103	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igg No model still on the market	W0105050102	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igm No model still on the market	W0105050103	100 Tests/Kit98/79 (no longer marketed) 200 Tests/Kit98/79 (no longer marketed) 30 Tests/Kit2 refs98/79 (no longer marketed) 50 Tests/Kit2 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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