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BEUDAMED

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3,381 results · 40ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k FDA registration 1k FDA 510(k) 332 Basic UDI-DI 89 Device 86 FDA Pre-Market Approval 64 FDA classification 13 Importer 4 Authorized representative 3 Manufacturer 3 + More Filters

Country

United States 2k Taiwan 409 China 322 United Arab Emirates 206 United Kingdom 101 Mexico 66 Germany 61 Canada 39 Switzerland 32 Sri Lanka 22 Vietnam 21 South Korea 19 Egypt 17 Japan 10 Spain 9 Hong Kong 8 Malaysia 7 Türkiye 7 Netherlands 6 Czechia 4 + More Countries

Manufacturer

Hbh Biotechnology Limited 18 Hs Doms Gmb H 16 Maccura Biotechnology Co., Ltd. 15 Xiamen Biotime Biotechnology Co., Ltd. 14 Shenzhen Superbio Technology Co.,Ltd. 12 Ellen Wille The Hair Company Gmb H 9 Hangzhou Alltest Biotech.Co.,Ltd. 7 Vitrosens Biyoteknoloji Anonim şirketi 6 Wuhan Life Origin Biotech Joint Stock Co., Ltd. 6 Tosoh Corporation 5 Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. 4 Assure Tech. (Hangzhou) Co., Ltd. 4 Beckman Coulter Inc. 4 Genrui Biotech Inc. 4 Getein Biotech, Inc. 4 Shenzhen Zijian Biotechnology Co., Ltd 4 Suzhou Hokapi Biomedical Engineering Co., Ltd.. 4 Hangzhou Cybereagen Biotech Co., Ltd. 3 Immunotech S.R.O. 3 Autobio Diagnostics Co., Ltd. 2 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 72 Federal Agency For Medicines And Health Products / / Health Products Division 19 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 17 De/Ca90 Thüringer Landesamt Für Verbraucherschutz Dezernat 21 Technischer Verbraucherschutz, Marktüberwachung 16 Agencia Española De Medicamentos Y Productos Sanitarios 9 De/Ca24 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 9 De/Ca22 Bezirksregierung Münster 8 Health Products Regulatory Authority, Medical Devices Department 7 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 6 Turkish Medicine And Medical Devices Agency 6 State Institute For Drug Control Medical Device Section 4 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 3 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 De/Ca39, Regierungspräsidium Freiburg Referat 25 2 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 2 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 1 National Agency For Medicines And Medical Devices Of Romania 1 The Medicines And Healthcare Products Regulatory Agency 1 + More Competent Authorities

Kind

Professional Testing 68 Reagent 66 Kit 60 Single Use 50 Animal Tissues 45 Human Tissues 15 Microbial Substances 12 Near Patient Testing 11 Sterile 9 Self Testing 6 New Device 4 Active 3 Companion Diagnostics 3 + More Kinds

Classification

FDA Class 2 326 Eu Ivd General 99 FDA Class 3 64 Eu Md Class 1 28 FDA Class 1 19 Eu Ivd Class A 18 Eu Ivd Self Testing 15 Eu Ivd Class B 12 Eu Md Class 2b 2 Eu Md Class 2a 1 + More Classifications

Notified Body

Tüv Süd Product Service Gmb H 12 Tüv Rheinland Lga Products Gmb H 3 Tuv Nord Polska Sp. Z O.O 2 + More Notified Bodies

FDA FEI Number

3000126629 225 3003971136 211 3009077524 207 3002807167 206 3013500228 199 3013596024 199 1218950 197 3003263092 196 3012528160 196 3016618143 196 3016701404 196 3017935637 196 1000140026 194 1527715 194 3004009431 194 3006733253 194 3010082909 194 3010381606 194 2017865 193 2938836 193 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Ivdd 114 Eu Ivdr 30 Eu Mdr 29 Eu Mdd 2 + More Regulations

Authorized Representative

Cmc Medical Devices & Drugs Sl 58 Shanghai International Holding Corp. Gmb H(europe) 47 Lotus Nl B.V. 40 Kingsmead Service B.V. 20 Medunion S.L. 20 Osen Gmb H 18 Sungo Cert Gmb H 16 Humiss International B.V. 15 Qb D Rep S Bv 14 Med Net Ec Rep Gmb H 12 Sungo Europe B.V. 10 Osmunda Medical Technology Service Gmb H 6 Tosoh Europe N.V. 5 Beckman Coulter Ireland Inc. 4 C Epartner4 U 4 Nic Gmb H 4 Riomavix Ltd 3 Acorn Regulatory Consultancy Services Ltd 1 Luxus Lebenswelt Gmb H 1 Mdss Gmb H 1 + More Authorized Representatives

FDA Registration Number

3000126629 225 3003971136 211 3009077524 207 9610816 205 3013500228 199 3013596024 199 1218950 197 3003263092 197 3012528160 196 3016618143 196 3016701404 196 3017935637 196 1527715 194 2132111 194 3004009431 194 3006733253 194 3010082909 194 3010381606 194 2017865 193 2938836 193 + More FDA Registration Numbers

FDA K Number

Den130049 1 Den240025 1 K001025 1 K003269 1 K004007 1 K011323 1 K013354 1 K020825 1 K021429 1 K021486 1 K022297 1 K022540 1 K022779 1 K031348 1 K032002 1 K032103 1 K033037 1 K033105 1 K033106 1 K033242 1 + More FDA K Numbers

Certificate Type

Ivdd Annex Iv (Excluding Sections 4, 6) 15 Mdd Annex Ii (Excluding Section 4) 2 + More Certificate Types

Status

On The Market 85 No Longer On The Market 1 + More Statuses

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

<1 …166 167 168 169 170 >

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

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EU MDR

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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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