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BEUDAMED

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6,961 results · 40ms · Sources: EU EUDAMED, US FDA

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Device 2k FDA UDI 2k Basic UDI-DI 2k FDA Pre-Market Approval 1k FDA registration 356 FDA 510(k) 89 Authorized representative 13 Importer 9 Certificate 7 FDA classification 6 Manufacturer 5 + More Filters

Country

United States 3k South Korea 3k Italy 302 China 105 Mexico 94 Hungary 59 Japan 50 Germany 34 France 14 Netherlands 12 Finland 10 India 9 Taiwan 8 Romania 7 United Kingdom 7 Belgium 5 Israel 5 Spain 5 Switzerland 5 Canada 4 + More Countries

Manufacturer

Mf / Sewonmedix Inc. 3k Xmed Mf 293 Pharmico Medical Korlátolt Felelősségi Társaság Mf 59 Jeol Ltd. Mf 47 Gold Probe Diagnostic Biotechnology Inc. Mf 28 Biofarm S.A. 5 Sensoplast Packmitteltechnik Gmb H 5 Deep Bio Mf 4 Pro Wellness Health Solutions Oy 4 Cytocell Limited 3 Farmaka Srl 3 Lunit Inc. 3 Medical Magnesium Gmb H 3 Sga Mühendi̇sli̇k Danişmanlik Eği̇ti̇m İç Ve Diş Ti̇caret Anoni̇m şi̇rketi̇ 3 Adhe Els Sa. 2 Alps South, Llc 2 Anton Hübner Gmb H & Co. Kg 2 Assure Tech. (Hangzhou) Co., Ltd. 2 Biose Industrie 2 Bl Tech 2 + More Manufacturers

Competent Authority

Malta Medicines Authority 3k Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 301 Ministry Of Health, Welfare And Sports 96 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 59 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 14 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 9 Agencia Española De Medicamentos Y Productos Sanitarios 7 National Agency For Medicines And Medical Devices Of Romania 7 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 5 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 4 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 4 De/Ca21 Bezirksregierung Köln Dezernat 24 4 Health Products Regulatory Authority, Medical Devices Department 4 Turkish Medicine And Medical Devices Agency 4 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 3 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 3 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 3 Federal Agency For Medicines And Health Products / / Health Products Division 3 The Medicines And Healthcare Products Regulatory Agency 3 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 3 + More Competent Authorities

Kind

Single Use 1k Sterilization 1k Implantable 962 Sterile 368 Reusable 331 Professional Testing 32 Active 29 Reagent 23 Kit 22 Software 19 Animal Tissues 15 Measuring Function 15 Near Patient Testing 15 Administering Medicine 11 Companion Diagnostics 4 Human Tissues 4 Instrument 4 Orthopedic 3 Self Testing 2 + More Kinds

Classification

Eu Md Class 2b 2k FDA Class 3 1k Eu Md Class 2a 1k Eu Md Class 1 441 FDA Class 2 79 Eu Ivd General 50 Eu Ivd Class A 40 FDA Class 1 15 Eu Md Class 3 8 Eu Ivd Class C 3 Eu Ivd Self Testing 2 Eu Ivd Annex 2 List B 1 Eu Ivd Class B 1 + More Classifications

Notified Body

Sgs Belgium Nv 3k Kiwa Cermet Italia S.P.A. 293 Neoemki Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (Neoemki Llc) 45 Tüv Süd Product Service Gmb H 7 Dqs Medizinprodukte Gmb H 6 Tüv Rheinland Lga Products Gmb H 6 Kiwa Belgelendirme Hizmetleri A.ş. 5 Mdc Medical Device Certification Gmbh 4 Bsi Group The Netherlands B.V. 3 Eurofins Electric & Electronics Finland Oy 3 Dnv Product Assurance As 2 Eurofins Product Testing Italy S.R.L. 2 National Evaluation Center Of Quality And Technology In Health S.A. Ekapty 2 Sgs Fimko Oy 2 Szutest Uygunluk Değerlendirme A.ş. 2 Centro Nacional De Certificacion De Productos Sanitarios 1 Certiquality S.R.L. 1 Gmed Sas 1 Istituto Superiore Di Sanita' 1 Italcert Srl 1 + More Notified Bodies

FDA FEI Number

1000306431 868 2011171 868 3002807314 868 1028232 867 2124215 867 3002807111 867 1000116158 866 1000121056 866 1820334 866 2024024 866 2024168 866 3009380063 866 3001451463 865 3001452571 865 3002095335 865 3002806434 865 3002806565 865 3002807091 865 3002807315 865 3002808050 865 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 3k Eu Mdr 413 Eu Ivdd 53 Eu Ivdr 44 + More Regulations

Authorized Representative

Advena Limited 3k Obelis S.A. 3k Jeol(europe)bv Ar 47 Lotus Nl B.V. 28 Ar Experts B.V. 4 C Epartner4 U 3 Shanghai International Holding Corp. Gmb H(europe) 3 Sysmex Europe Gmb H 3 Sysmex Europe Se 3 Wellkang Ltd 3 Adhe Els France 2 Amstermed B.V. 2 Cmc Medical Devices & Drugs Sl 2 International Associates Auditing & Certification Limited 2 Medical Technology Promedt Consulting Gmb H 2 Sandine Zartaux Cy Ltd 2 Acist Europe Bv 1 Bayer Vital Gmb H 1 Ddsa Pharma Ee 1 Emergo Europe B.V. 1 + More Authorized Representatives

FDA Registration Number

2011171 868 2029275 868 3002807314 868 1028232 867 2124215 867 3005941719 867 1000121056 866 1225687 866 1820334 866 2024024 866 2024168 866 2134265 866 3009380063 866 2184009 865 2939561 865 2953200 865 3002807315 865 3004091615 865 3005111382 865 3005718570 865 + More FDA Registration Numbers

FDA K Number

K000105 1 K000852 1 K142432 1 K152178 1 K171366 1 K183579 1 K190047 1 K191435 1 K200482 1 K200848 1 K202781 1 K211965 1 K221303 1 K232415 1 K233162 1 K243678 1 K831764 1 K853600 1 K874050 1 K874051 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 3k Mdd Annex V 11 Mdd Annex Ii Section 4 7 Mdd Annex Vi 5 Ivdd Annex Iv (Excluding Sections 4, 6) 3 + More Certificate Types

Status

On The Market 2k + More Statuses

Lotus NL B.V.

Authorized representative

🇳🇱 Netherlands·584 Manufacturers·21427 Devices

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

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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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