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BEUDAMED

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2,921 results · 38ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA registration 562 FDA 510(k) 223 Device 60 Basic UDI-DI 43 Manufacturer 4 Authorized representative 3 FDA classification 3 Certificate 1 FDA Pre-Market Approval 1 Importer 1 + More Filters

Country

United States 2k China 118 Belize 88 Italy 83 Mexico 41 Germany 39 Finland 30 Canada 25 United Kingdom 20 Spain 18 Taiwan 16 Israel 13 India 12 Malaysia 9 Hong Kong 8 Netherlands 7 Türkiye 6 Denmark 4 Ireland 4 Poland 3 + More Countries

Manufacturer

Ledraplastic Spa 33 Aga Sanitätsartikel Gmb H 13 Bq Plus Medical Co., Ltd. 10 Ortoiberica S.L. 10 Movendos Oy 7 Oiva Health Oy 7 Vitrosens Biyoteknoloji Anonim şirketi 6 Nanjing Synthgene Medical Technology Co., Ltd. 4 Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. 2 Beijing Jinwofu Bioengineering Technology Co., Ltd. 2 Hangzhou Immuno Biotech Co., Ltd 2 Viva Chek Biotech (Hangzhou) Co., Ltd. 2 Xiamen Biotime Biotechnology Co., Ltd. 2 Air Water Realize Inc. 1 Accu Pulse Medical Device (Suzhou) Ltd. 1 Affacare Medical (Beijing) Co., Ltd. 1 Alfa Medtech (Shanghai) Co., Ltd. 1 Anhui Jn Medical Device Co.,Ltd. 1 Anhui Med Purest Medical Technology Co., Ltd. 1 Anji Anshen Surgical Dressings Co., Ltd. 1 + More Manufacturers

Competent Authority

Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 33 Agencia Española De Medicamentos Y Productos Sanitarios 24 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 14 De/Ca19 Bezirksregierung Detmold Dezernat 24 13 Ministry Of Health, Welfare And Sports 10 Turkish Medicine And Medical Devices Agency 6 De/Ca304 Marktüberwachung Medizinprodukte Bayern 4 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 3 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Infarmed – National Authority Of Medicines And Health Products, I.P 1 The Medicines And Healthcare Products Regulatory Agency 1 + More Competent Authorities

Kind

Single Use 16 Active 15 Software 14 Kit 11 Professional Testing 11 Reagent 11 Near Patient Testing 4 Animal Tissues 3 Companion Diagnostics 3 Sterile 3 Sterilization 2 Self Testing 1 + More Kinds

Classification

FDA Class 2 205 Eu Md Class 1 76 Eu Ivd General 23 FDA Class 1 20 Eu Md Class 2a 3 Eu Ivd Self Testing 1 FDA Class 3 1 FDA Unclassified 1 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 9 + More Notified Bodies

FDA FEI Number

3012307300 202 3010605677 201 2936999 197 3004748541 193 3006157842 193 3002806783 192 3008729547 191 3000126629 190 2011171 187 3002807167 187 3004415095 185 3011353843 185 3002737156 184 3013500228 183 3013596024 183 1000160458 181 3001451571 181 3012359877 181 3003076831 180 3003971136 180 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdr 59 Eu Ivdd 24 Eu Mdd 20 + More Regulations

Authorized Representative

Lotus Nl B.V. 13 Prolinx Gmb H 8 Zoustech S.L. 8 Cmc Medical Devices & Drugs Sl 6 Kingsmead Service B.V. 5 Med Path Gmb H 4 Medunion S.L. 4 Bzt Tcp Certification Gmb H 2 C Epartner4 U 2 Osen Gmb H 2 Shanghai International Holding Corp. Gmb H(europe) 2 Sungo Cert Gmb H 2 Luxus Lebenswelt Gmb H 1 Mdss Gmb H 1 Riomavix Ltd 1 Wellkang Ltd 1 + More Authorized Representatives

FDA Registration Number

3012307300 202 3010605677 201 2936999 197 3004748541 193 3006157842 193 3008729547 191 3000126629 190 2011171 187 3004415095 185 3011353843 185 1651104 184 3013500228 183 3013596024 183 1320894 181 2029015 181 2032112 181 3012359877 181 3003971136 180 3009617712 180 3009831876 180 + More FDA Registration Numbers

FDA K Number

K000406 1 K001030 1 K001743 1 K003704 1 K011329 1 K022311 1 K040605 1 K051779 1 K062883 1 K070375 1 K080922 1 K082465 1 K090273 1 K092062 1 K092685 1 K100773 1 K103631 1 K111933 1 K120465 1 K122223 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 8 Ivdd Annex Iv (Excluding Sections 4, 6) 1 + More Certificate Types

Status

On The Market 60 + More Statuses

Prolinx GmbH

Authorized representative

🇩🇪 Germany·97 Manufacturers·1780 Devices

<1 …143 144 145 146 147 >

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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