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BEUDAMED

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3,341 results · 35ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 247 Basic UDI-DI 241 FDA Pre-Market Approval 62 FDA 510(k) 48 Device 12 FDA classification 3 Importer 3 Manufacturer 3 Authorized representative 2 + More Filters

Country

United States 3k Ireland 183 China 121 United Kingdom 49 Taiwan 29 Italy 27 Germany 14 Samoa 10 Denmark 8 India 6 Malaysia 6 Japan 3 Mexico 3 Russian Federation 3 Canada 2 France 2 Netherlands 2 Bangladesh 1 Hong Kong 1 Israel 1 + More Countries

Manufacturer

Ortho Xel Dac 181 Jiangsu Bioperfectus Technologies Co., Ltd. 16 Bgi Europe A/S 8 Serumwerk Bernburg Vertriebs Gmb H 6 Hartalega Ngc Sdn. Bhd. 5 Serumwerk Bernburg Ag 5 Centurion Medical Products, Lp (F/K/A Centurion Medical Products Corporation) 4 Hangzhou Genesis Biodetection And Biocontrol Co., Ltd. 3 Shenzhen Zijian Biotechnology Co., Ltd 3 Xiamen Boson Biotech Co., Ltd. 3 Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. 2 Atlas Medical Gmb H 2 Besmed Health Business Corp. 2 Cook Bio Device 2 Cook Incorporated 2 Nanjing Synthgene Medical Technology Co., Ltd. 2 Ooo Npf "Rehabilitation Technologies" 2 3 Cpm Company, Inc. 1 A.B. Dental Devices Ltd 1 A.R Guide In Medical Ltd. 1 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 185 Ministry Of Health, Welfare And Sports 21 De/Ca22 Bezirksregierung Münster 16 De/Ca87 Landesamt Für Verbraucherschutz Des Landes Sachsen Anhalt Dezernat 51 Zentraldezernat Arbeitsschutz 11 Danish Medicines Agency, Pharmacovigilance & Medical Devices 8 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 5 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 3 De/Ca304 Marktüberwachung Medizinprodukte Bayern 2 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 2 Malta Medicines Authority 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 Infarmed – National Authority Of Medicines And Health Products, I.P 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 + More Competent Authorities

Kind

Orthopedic 181 Implantable 180 Professional Testing 45 Reagent 43 Kit 42 Animal Tissues 34 Near Patient Testing 25 Microbial Substances 16 Single Use 9 Measuring Function 2 Reusable 1 + More Kinds

Classification

Eu Md Class 2b 191 FDA Class 3 62 FDA Class 2 48 Eu Ivd General 43 Eu Md Class 1 13 Eu Md Class 2a 4 FDA Class 1 3 Eu Ivd Class B 1 Eu Ivd Class C 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 180 Mdc Medical Device Certification Gmbh 6 Dekra Certification B.V. 2 Gmed Sas 1 + More Notified Bodies

FDA FEI Number

3001168737 48 3011647251 32 3013180212 30 3009546990 26 3018094310 22 3007499787 21 3023189540 21 1028232 15 3002806500 15 3010536692 15 1000125183 13 1000306340 13 1450662 13 1526534 13 2017865 13 2124215 13 2182208 13 2649622 13 2938836 13 3000203466 13 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 191 Eu Ivdd 43 Eu Mdr 17 Eu Ivdr 2 + More Regulations

Authorized Representative

Med Net Ec Rep Gmb H 19 Shanghai International Holding Corp. Gmb H(europe) 17 Lotus Nl B.V. 12 Cmc Medical Devices & Drugs Sl 8 Mdss Gmb H 5 C Epartner4 U 4 Nic Gmb H 3 Advena Limited 2 Casus Europe B.V. 2 Kingsmead Service B.V. 2 Med Path Gmb H 2 Mdi Europa Gmb H 2 Acorn Regulatory Consultancy Services Ltd 1 Amity Healthcare Eu Ltd. 1 Amstermed B.V. 1 Emergo Europe B.V. 1 Etac Supply Center Ab 1 Human Gesellschaft Für Biochemica Und Diagnostica Mb H 1 Ki Mobility Portugal, Unipessoal Lda 1 Medline International France 1 + More Authorized Representatives

FDA Registration Number

8021896 48 3011647251 32 3013180212 30 3009546990 26 3018094310 22 3007499787 21 3023189540 21 1028232 15 3010536692 15 9610139 15 1450662 13 1526534 13 1828464 13 1834331 13 2017865 13 2028492 13 2032521 13 2124215 13 2133641 13 2135338 13 + More FDA Registration Numbers

FDA K Number

Den200069 1 K133352 1 K213882 1 K230337 1 K243558 1 K243891 1 K771357 1 K771671 1 K780936 1 K791176 1 K810031 1 K821511 1 K821691 1 K832080 1 K832190 1 K862773 1 K881099 1 K882409 1 K893431 1 K912356 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 189 + More Certificate Types

Status

On The Market 12 + More Statuses

cottony II tape

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

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

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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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