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BEUDAMED

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7,061 results · 42ms · Sources: EU EUDAMED, US FDA

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FDA registration 3k FDA UDI 2k Basic UDI-DI 697 FDA Pre-Market Approval 567 Device 465 FDA 510(k) 452 FDA classification 22 Importer 8 Manufacturer 6 Authorized representative 5 System producer 1 + More Filters

Country

United States 4k China 1k Israel 370 Spain 243 United Arab Emirates 187 France 93 United Kingdom 88 Türkiye 70 Japan 57 Taiwan 49 Finland 48 Germany 42 Hong Kong 41 Italy 30 Denmark 24 Poland 20 Australia 18 India 18 Canada 17 Hungary 15 + More Countries

Manufacturer

Sansure Biotech Inc. 120 Maccura Biotechnology Co., Ltd. 102 Jiangsu Macro & Micro Test Med Tech Co., Ltd. 78 Vitrosens Biyoteknoloji Anonim şirketi 66 Anhui Deepblue Medical Technology Co.,Ltd 56 Shenzhen Zijian Biotechnology Co., Ltd 38 Jiangsu Bioperfectus Technologies Co., Ltd. 36 Xiamen Biotime Biotechnology Co., Ltd. 29 Jiangsu Mole Bioscience Co., Ltd. 28 Shanghai Zj Bio Tech Co., Ltd 28 Beckman Coulter Inc. 24 Nano Repro Ag 20 Hangzhou Immuno Biotech Co., Ltd 18 Acon Biotech (Hangzhou) Co., Ltd. 16 Nantong Egens Biotechnology Co.,Ltd. 16 Shenzhen Microprofit Biotech Co., Ltd. 16 Dynamiker Biotechnology (Tianjin) Co., Ltd. 15 Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch 14 Nanjing Synthgene Medical Technology Co., Ltd. 14 Shanghai Geneo Dx Biotech Co., Ltd. 14 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 407 Federal Agency For Medicines And Health Products / / Health Products Division 168 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 108 Agencia Española De Medicamentos Y Productos Sanitarios 92 De/Ca22 Bezirksregierung Münster 91 Turkish Medicine And Medical Devices Agency 69 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 48 The Medicines And Healthcare Products Regulatory Agency 33 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 29 Health Products Regulatory Authority, Medical Devices Department 25 Malta Medicines Authority 21 De/Ca36 Regierungspräsidium Gießen Abteilung Ii Dezernat 25.1 Arbeitsschutz Gießen I 20 De/Ca304 Marktüberwachung Medizinprodukte Bayern 14 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 13 De/Ca24 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 12 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 7 štátny ústav Pre Kontrolu Liečiv / State Institute For Drug Control ( Slovak Ca) 6 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 5 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 4 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 4 + More Competent Authorities

Kind

Kit 625 Reagent 622 Professional Testing 542 Single Use 331 Animal Tissues 309 Microbial Substances 210 Near Patient Testing 144 Self Testing 132 Human Tissues 59 Companion Diagnostics 35 Sterilization 17 Instrument 10 Sterile 5 Active 4 New Device 4 Measuring Function 3 Software 1 + More Kinds

Classification

Eu Ivd General 903 FDA Class 2 571 FDA Class 3 440 Eu Ivd Self Testing 203 Eu Md Class 1 25 Eu Md Class 2b 13 FDA Class 1 13 Eu Ivd Class A 10 FDA Not Classified 8 Eu Ivd Class D 5 FDA Unclassified 3 Eu Ivd Class C 2 Eu Md Class 2a 1 + More Classifications

Notified Body

Polskie Centrum Badan I Certyfikacji S.A. 128 Ce Cert Sp. Z O.O. 31 Tüv Süd Product Service Gmb H 26 Mdc Medical Device Certification Gmbh 20 Sertio Oy 7 Tüv Rheinland Lga Products Gmb H 4 Tuv Nord Polska Sp. Z O.O 3 Dekra Certification B.V. 1 + More Notified Bodies

FDA FEI Number

1825034 773 3002806559 354 2432235 309 1219913 301 2011171 250 3003795116 220 1219029 208 3006198300 205 1217183 201 3023162659 201 3003971136 198 3012104670 195 3015997711 195 1181121 194 1721676 193 2050012 193 3002637618 192 1036362 191 1220972 191 3007662974 191 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Ivdd 1k Eu Mdr 27 Eu Ivdr 17 Eu Mdd 12 + More Regulations

Authorized Representative

Lotus Nl B.V. 466 Cmc Medical Devices & Drugs Sl 318 Shanghai International Holding Corp. Gmb H(europe) 285 Obelis S.A. 158 Medunion S.L. 154 Osen Gmb H 151 Med Net Ec Rep Gmb H 145 Humiss International B.V. 103 Sungo Europe B.V. 79 Luxus Lebenswelt Gmb H 69 Mega Eurostar Sp. Z O.O. 61 Riomavix Ltd 55 Nic Gmb H 38 Wellkang Ltd 32 Kingsmead Service B.V. 31 Sungo Cert Gmb H 30 Pure Ce B.V. 25 Beckman Coulter Ireland Inc. 24 Advena Limited 14 Med Path Gmb H 14 + More Authorized Representatives

FDA Registration Number

1825034 773 9610126 354 2432235 309 1219913 301 2011171 250 3003795116 220 1219029 208 3006198300 205 1217183 201 3023162659 201 3003971136 198 3012104670 195 3015997711 195 1181121 194 1721676 193 2050012 193 1036362 192 3002637618 192 1220972 191 3007662974 191 + More FDA Registration Numbers

FDA K Number

Den170017 1 Den200031 1 Den210038 1 Den210040 1 Den220028 1 Den220039 1 K000103 1 K002290 1 K002613 1 K002738 1 K011679 1 K012058 1 K012352 1 K012478 1 K012805 1 K013729 1 K014295 1 K020297 1 K021515 1 K021713 1 + More FDA K Numbers

Certificate Type

Ivdd Annex Iii Section 6 145 Ivdd Annex Iv (Excluding Sections 4, 6) 62 Ivdr Technical Documentation 7 Mdd Annex Ii Section 4 3 Ivdd Annex Iv Section 4 2 Mdd Annex Ii (Excluding Section 4) 1 + More Certificate Types

Status

On The Market 451 No Longer On The Market 14 + More Statuses

Wellkang Ltd

Authorized representative

259 Manufacturers·3500 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

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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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