Manufacturer

Atlas Medical

GermanyLegal entities : Atlas Medical GmbH

Markets : Austria · Germany · Romania · United States

Approvals : United States (FDA) – 510(k) : 3 · class I, II · latest in 2019 · see on the FDA website

Public contracts won : Romania 136

Website info@atlas-medical.com

24 categories, 100 models including 100 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
Salmonella detection by NA reagents	W0105011003	Atlas Salmonella Antigen , Widal (6 Antigens: OA, OB, OD, HA, HB, HD) 8.01.18.0.003098/79 Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD), With controls. 8.01.16.1.004098/79 Atlas Salmonella Antigen Set: 8 Antigens ( OA,OB,OC,OD, HA,HB,HC,HD). 8.01.16.0.004098/79 Atlas Salmonella HA Reagent , 5 ml/vial, 8 vials/Box. 8.01.05.1.004098/79 Atlas Salmonella HA Reagent, 5 ml/vial, 1 vial/Box. 8.01.05.0.000598/79 14 others Atlas Salmonella HB Reagent, 5 ml/vial, 1 vial/Box. 8.01.06.0.000598/79 Atlas Salmonella HB Reagent, 5 ml/vial, 8 vials/Box. 8.01.06.1.004098/79 Atlas Salmonella HC Reagent, 5 ml/vial, 1 vial/Box. 8.01.07.0.000598/79 Atlas Salmonella HC Reagent, 5 ml/vial, 8 vials/Box. 8.01.07.1.004098/79 Atlas Salmonella HD Reagent, 5 ml/vial, 1 vial/Box. 8.01.08.0.000598/79 Atlas Salmonella HD Reagent, 5 ml/vial, 8 vials/Box. 8.01.08.1.004098/79 Atlas Salmonella OA Reagent , 5 ml/vial, 1 vial/Box. 8.01.01.0.000598/79 Atlas Salmonella OA Reagent , 5 ml/vial, 8 vials/Box. 8.01.01.1.004098/79 Atlas Salmonella OB Reagent , 5 ml/vial, 8 vials/Box. 8.01.02.1.004098/79 Atlas Salmonella OB Reagent, 5 ml/vial, 1 vial/Box. 8.01.02.0.000598/79 Atlas Salmonella OC Reagent , 5 ml/vial, 8 vials/Box. 8.01.03.1.004098/79 Atlas Salmonella OC Reagent, 5 ml/vial, 1 vial/Box. 8.01.03.0.000598/79 Atlas Salmonella OD Reagent , 5 ml/vial, 8 vials/Box. 8.01.04.1.004098/79 Atlas Salmonella OD Reagent, 5 ml/vial, 1 vial/Box. 8.01.04.0.000598/79	– 98/79	EUDAMED record Report an error
Abo typing tests - other	W0103030199	ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/plastic Pack 8.02.05.6.003098/79 ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-D (1/128)), 3x10ml/Plastic Pack 8.02.47.0.003098/79 ABO Set: Anti-A (1/256), Anti-B (1/256), 2x10ml/Plastic Pack 8.02.05.7.002098/79 Anti-A Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1 Vial/carton Box 8.02.04.0.001098/79 Anti-A Monoclonal Reagent (Titer: 1/256), 10ml/vial, 10 vials/Plastic Pack 8.02.04.0.010098/79 10 others Anti-A Monoclonal Reagent (Titer: 1/512), 10ml/vial. 10 vials/Plastic Pack 8.02.00.1.010098/79 Anti-AB Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1vial/carton Box 8.02.06.0.001098/79 Anti-AB Monoclonal Reagent (Titer: 1/256), 10ml/vial,10 vials/Plastic Pack 8.02.06.1.010098/79 Anti-AB Monoclonal Reagent (Titer: 1/512), 10ml/vial, 1 vial/carton Box 8.02.02.0.001098/79 Anti-AB Monoclonal Reagent (Titer: 1/512), 10ml/vial, 10 vials/Plastic Pack 8.02.02.1.010098/79 Anti-B Monoclonal Reagent (Titer: 1/256), 10ml/vial, 10 vials/Plastic Pack 8.02.05.0.010098/79 Anti-B Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1vial/carton Box 8.02.05.0.001098/79 Anti-B Monoclonal Reagent (Titer: 1/512), 10ml/vial, 1 vial/carton Box 8.02.01.0.001098/79 Anti-B Monoclonal Reagent (Titer: 1/512), 10ml/vial, 10 vials/Plastic Pack 8.02.01.1.010098/79 Atlas Anti-A Monoclonal Reagent (Titer: 1/512), 10ml/vial, 1 vial/carton Box 8.02.00.0.001098/79	– 98/79	EUDAMED record Report an error
Syphilis reagents other	W0105010399	Atlas RPR Carbon Antigen Kit, 100 Tests 8.00.18.0.010098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls) 8.00.18.3.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks). 8.00.18.2.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks, White Glass Slide). 8.00.18.7.050098/79 Atlas RPR Carbon Antigen Kit, 500 Tests 8.00.18.0.050098/79 5 others Atlas RPR Carbon Antigen Reagent, 5 ml/Vial, 1 Vial/Box. 8.00.18.2.000598/79 Atlas TPHA Kit, 100 Tests 8.00.19.0.010098/79 Atlas TPHA Kit, 200 Tests 8.00.19.0.020098/79 Atlas VDRL Kit , 2500 Tests 8.00.20.0.250098/79 RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks). 8.00.18.2.010098/79	– 98/79	EUDAMED record Report an error
Brucella	W0105011701	Atlas Brucella Abortus Reagent, 5 ml/vial, 1 vial/Box. 8.01.10.0.000598/79 Atlas Brucella Abortus Reagent, 5 ml/vial, 8 vials/Box. 8.01.10.1.004098/79 Atlas Brucella Antigen Kit with Controls, (5ml Brucella melitensis, 5ml Brucella abortus, 2x1.0 ml Controls) 8.01.15.1.001098/79 Atlas Brucella Antigen Kit, (5ml Brucella Melitensis, 5ml Brucella Abortus) 8.01.15.0.001098/79 Atlas Brucella Melitensis Reagent, 5 ml/vial, 1 vial/Box. 8.01.11.0.000598/79 4 others Atlas Brucella Melitensis Reagent, 5 ml/vial, 8 vials/Box. 8.01.11.1.004098/79 Atlas Brucella Rose Bengal kit , 100 Tests 8.01.00.0.010098/79 Atlas Brucella Rose Bengal Kit , 50 Tests 8.01.00.0.005098/79 Atlas Brucella Rose Bengal Reagent, 5ml/vial 8.01.00.0.000598/79	– 98/79	EUDAMED record Report an error
Proteus	W0105011712	Atlas Proteus OX19 Reagent, 5 ml/vial, 1 vial/Box. 8.01.13.0.000598/79 Atlas Proteus OX19 Reagent, 5 ml/vial, 8 vials/Box. 8.01.13.1.004098/79 Atlas Proteus OX2 Reagent, 5 ml/vial, 1 vial/Box. 8.01.12.0.000598/79 Atlas Proteus OX2 Reagent, 5 ml/vial, 8 vials/Box. 8.01.12.1.004098/79 Atlas Proteus OXK Reagent, 5 ml/vial, 1 vial/Box. 8.01.14.0.000598/79 1 other Atlas Proteus OXK Reagent, 5 ml/vial, 8 vials/Box. 8.01.14.1.004098/79	– 98/79	EUDAMED record Report an error
Combined abo typing + rhesus d	W0103030901	ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-AB (1/256), Anti-D (1/64)), 4x10ml/carton Box 8.02.49.0.004098/79 ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/ Plastic Pack 8.02.47.3.003098/79 ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/carton Box. 8.02.47.1.003098/79 ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml, 4vials/Plastic Pack 8.02.53.1.004098/79 ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml/Plastic Pack 8.02.53.0.004098/79	– 98/79	EUDAMED record Report an error
Enhancement media (e.g. bovine albumin, liss, peg)	W0103030306	Atlas Bovine Albumin 22%, 10 ml/Vial, 10 vials/Pack. 8.02.08.1.010098/79 Atlas Bovine Albumin 22%, 10ml/vial,1 Vial/Box 8.02.08.0.001098/79 Atlas Bovine Albumin 30%, 10 ml/Vial, 1 vial/Box 8.02.09.0.001098/79 Atlas Bovine Albumin 30%, 10 ml/Vial, 10 vials/Pack. 8.02.09.1.010098/79	– 98/79	EUDAMED record Report an error
Rhesus d	W0103030201	Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 1 vial/carton Box 8.02.03.0.001098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 10 vials/Plastic Pack 8.02.03.1.010098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 10 vials/Plastic Pack 8.02.07.1.010098/79 Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 1Vial/carton Box 8.02.07.0.001098/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	Atlas D-Dimer Latex Kit, 25 Tests 8.00.17.0.002598/79 Atlas D-Dimer Latex, 100 Tests 8.00.17.0.010098/79 Atlas D-Dimer Latex, 50 Tests 8.00.17.0.005098/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 20 Tests/Box 8.04.86.0.002098/79 Atlas Influenza A&B Test Device, Nasopharyngeal Sample, Individually Pouched, 25Tests/box 8.04.86.0.002598/79 Atlas Influenza A&B Test Strip, Nasopharyngeal Sample, Individually Pouched, 25 Tests/Box. 8.04.96.0.002598/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time - RT & POC	W0103020802	Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2 ml /Vial, 1 Vial/Box. 8.02.41.1.004098/79 Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2x2 ml APTT reagent, 1x1 ml Normal Control, 3 Vials /Box. 8.02.45.0.008098/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Atlas Adenovirus Antigen Test Device, Stool Sample, Individually Pouched, 20 Tests/Box. 8.04.71.0.002098/79 Atlas Adenovirus Respiratory Test Device, Nasopharyngeal Sample, Individually Pouched, 20 Tests/Box 8.16.37.0.002098/79	– 98/79	EUDAMED record Report an error
Ebv reagents - other	W0105040499	Atlas IM Latex , 100 Tests 8.00.08.0.010098/79 Atlas IM Latex Kit, 50 Tests (2ml Reagent, 2x0.5mlControls) 8.00.31.0.005098/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Atlas Rotavirus -Adenovirus Antigens Test Device, Stool Sample, Individually Pouched, 20 Tests/Box. 8.04.73.0.002098/79 Atlas Rotavirus -Adenovirus Antigens Test Strip, Stool Sample, Individually Pouched, 25 Tests/Box. 8.04.74.0.002598/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Atlas H.pylori Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.23.1.002098/79 Atlas H.pylori Antigen Test Strip, 3.5mm, Stool Sample, Individually Pouched, 25 Test/Box (Buffer to be supplied in Extraction Tubes) 8.04.24.1.002598/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Atlas H.pylori Antibody Test Device, Serum/Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas H.pylori Antibody Test Device, Whole Blood/Serum/Plasma, Individually Pouched H.pylori Antibody Test Device, Whole Blood/Serum/Plasma, Individually Pouched, 20 Tests/Box98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Atlas 8.04.37.0.002098/79 Atlas Malaria PF/PV , test cassette, Whole blood, Individually packed, 20 Test/Box 8.16.14.0.002098/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Atlas Syphilis Antibody Test Device, Whole Blood /Serum /Plasma, Individually Pouched, 20 Tests/Box98/79 Atlas Syphilis Antibody Test Strip, Serum/Plasma, Individually Pouched, 50 Tests/Box 8.04.43.0.005098/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	AtlasvDrabkins Reagent, 40x, 50ml/vial (500 Tests) 8.02.46.1.050098/79	– 98/79	EUDAMED record Report an error
Haematology controls - other	W0103010599	Atlas Sickle cell positive and negative control set. 8.02.68.0.000198/79	– 98/79	EUDAMED record Report an error
Lupus anticoagulant	W0103020606	Atlas SLE Latex , 50 Tests 8.00.11.0.005098/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Atlas Rotavirus Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.69.0.002098/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Atlas Adeno - RSV Respiratory Test Device, Nasopharyngeal Sample Individually Pouched, 20 Tests/Box 8.16.39.0.002098/79	– 98/79	EUDAMED record Report an error
Staphylococci reagents - other	W0105011299	Atlas Staphylococcus Latex , 100 Tests 8.00.12.0.010098/79	– 98/79	EUDAMED record Report an error

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