LUMITEX, INC. - BEUDAMED

BEUDAMED

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221 results · 63ms · Sources: EU EUDAMED, US FDA

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FDA UDI 160 FDA 510(k) 29 FDA registration 25 Manufacturer 3 Authorized representative 2 Importer 2 + More Filters

Country

United States 170 Canada 46 Belgium 1 Germany 1 Italy 1 Mexico 1 Netherlands 1 + More Countries

Manufacturer

Cadwell Industries, Inc. 2 Lumitex Medical Devices, Inc. 2 1drop Inc. 1 3 D Systems, Inc. 1 6over6 Vision Ltd 1 A.Titan Instruments 1 Ace Surgical Supply Co., Inc. 1 Ach Medical Co., Ltd. 1 Acon Laboratories, Inc. 1 Addon Optics Ltd 1 Airway Manangement Inc 1 Apacor Limited 1 Arsci Inc. 1 Ast Vision Care Inc. 1 Avecena Gloves Sdn. Bhd. 1 A Vi Ta Corporation 1 Aalto Scientific, Ltd. 1 Abbott Diagnostics Medical Co., Ltd. 1 Abbott Toxicology Ltd 1 Acclaro Corporation 1 + More Manufacturers

Competent Authority

De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 3 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 Federal Agency For Medicines And Health Products / / Health Products Division 1 Ministry Of Health, Welfare And Sports 1 + More Competent Authorities

Classification

FDA Class 2 28 FDA Class 1 1 + More Classifications

FDA FEI Number

3002777243 45 3002773840 18 3004530258 18 3006028115 18 3009613136 18 3002524000 17 3005670738 17 3007799234 17 3015550354 17 2023365 10 2024800 10 2243471 10 3003795116 10 3004141078 10 3005248192 10 3012494290 10 3016838963 10 1000122536 9 1000161215 9 1119779 9 + More FDA FEI Numbers

Regulation

Us FDA 214 + More Regulations

Authorized Representative

Mdss Gmb H 2 Dia Sorin Italia S.P.A. 1 + More Authorized Representatives

FDA Registration Number

3002777243 45 3002773840 18 3004530258 18 3006028115 18 3009613136 18 1650733 17 3005360469 17 3007799234 17 3015550354 17 2023365 10 2024800 10 2243471 10 3003795116 10 3004141078 10 3005248192 10 3012494290 10 3016838963 10 1119779 9 1221359 9 1528450 9 + More FDA Registration Numbers

DiaSorin Italia S.p.A.

Authorized representative

🇮🇹 Italy·5 Manufacturers

<1 …8 9 10 11 12 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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Tools

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

EU IVDR

EU IVDR In Vitro Diagnostic Devices EU IVDR Class A In Vitro Diagnostic Devices EU IVDR Class A Software Devices EU IVDR Class B In Vitro Diagnostic Devices EU IVDR Class B Software Devices EU IVDR Class C In Vitro Diagnostic Devices EU IVDR Class C Software Devices EU IVDR Class D In Vitro Diagnostic Devices EU IVDR Class D Software Devices EU IVDR Instrument Devices EU IVDR Kit Devices EU IVDR Reagent Devices EU IVDR Software Devices

FDA

FDA Medical Devices FDA Class I Medical Devices FDA Class II Medical Devices FDA Class III Medical Devices

By Country

EU IVDR Medical Devices from China EU IVDR Medical Devices from France EU IVDR Medical Devices from Germany EU IVDR Medical Devices from Romania EU IVDR Medical Devices from United States EU MDR Medical Devices from China EU MDR Medical Devices from Egypt EU MDR Medical Devices from Finland EU MDR Medical Devices from France EU MDR Medical Devices from Germany EU MDR Medical Devices from Italy EU MDR Medical Devices from Pakistan EU MDR Medical Devices from Poland EU MDR Medical Devices from Spain EU MDR Medical Devices from Türkiye EU MDR Medical Devices from United Kingdom EU MDR Medical Devices from United States

Notified Bodies

BSI Group The Netherlands B.V. DEKRA Certification B.V. DNV Product Assurance AS POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. SGS Belgium NV TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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