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BEUDAMED

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9,741 results · 48ms · Sources: EU EUDAMED, US FDA

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FDA registration 4k FDA UDI 3k FDA 510(k) 2k FDA Pre-Market Approval 247 Basic UDI-DI 240 Device 160 Manufacturer 29 Importer 14 Certificate 9 Authorized representative 7 FDA classification 6 System producer 3 + More Filters

Country

Malaysia 5k United States 4k China 211 South Korea 130 Vietnam 109 Malta 57 Taiwan 39 Canada 35 Italy 33 Germany 30 Israel 26 Egypt 25 Switzerland 25 Thailand 21 Estonia 19 Sweden 16 Poland 15 Singapore 15 France 13 Hong Kong 13 + More Countries

Manufacturer

Osstem Orthodontics Inc. 118 Zirc Dental Products Inc. 64 Miracle Medical Industries 25 Geon Corporation 21 Cbs Medical Srl 20 Mdt Int'l Sa 18 Mdt Micro Diamond Technologies Ltd. 17 Tronjen Medical Technology Inc. 15 Mondottica Limited 12 General Medical Merate S.P.A. 9 Stericon Pharma Pvt.Ltd 9 Gh Innotek Co., Ltd. 8 Polydentia Sa 7 Alison Hayes (Romania) Srl 6 Garrison Dental Solutions Llc 5 Guilin Woodpecker Medical Instrument Co., Ltd. 5 Angelus Indústria De Produtos Odontológicos S/A 4 Contin Technology Limited 4 Den Mat Holdings, Llc 4 Hangzhou Kelang Trading Co., Ltd 4 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 129 Agencia Española De Medicamentos Y Productos Sanitarios 103 De/Ca21 Bezirksregierung Köln Dezernat 24 65 Federal Agency For Medicines And Health Products / / Health Products Division 40 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 31 De/Ca22 Bezirksregierung Münster 16 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 11 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 9 Malta Medicines Authority 8 National Agency For Medicines And Medical Devices Of Romania 6 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 5 De/Ca11 Staatliches Gewerbeaufsichtsamt Oldenburg Dezernat Gesundheitswesen, Medizinprodukte Und Strahlenschutz 4 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 4 Health Products Regulatory Authority, Medical Devices Department 4 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 3 De/Ca10 Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte 3 Office Of Public Health 3 Turkish Medicine And Medical Devices Agency 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 2 De/Ca304 Marktüberwachung Medizinprodukte Bayern 2 + More Competent Authorities

Kind

Single Use 41 Sterile 16 Active 14 Measuring Function 10 Sterilization 8 Reusable 6 Implantable 5 Kit 3 Professional Testing 3 Reagent 3 Latex 2 Orthopedic 2 Administering Medicine 1 Animal Tissues 1 Human Tissues 1 Medicinal Product 1 + More Kinds

Classification

FDA Class 1 1k FDA Class 2 270 FDA Class 3 248 Eu Md Class 1 217 Eu Md Class 2a 159 Eu Md Class 3 12 FDA Unclassified 12 Eu Md Class 2b 8 Eu Ivd Class A 1 Eu Ivd Class B 1 Eu Ivd Class C 1 Eu Ivd General 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 118 Dnv Product Assurance As 44 Dekra Certification B.V. 13 Istituto Superiore Di Sanita' 7 Tüv Rheinland Lga Products Gmb H 4 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 3 Italcert Srl 1 + More Notified Bodies

FDA FEI Number

3010220595 1k 3002808507 1k 3012421607 1k 3002807146 1k 3013557562 1k 3011200663 1k 3009538921 1k 3008253024 1k 3006367442 1k 1417592 1k 3001236905 1k 3010175289 1k 3020521811 1k 3012441043 1k 1000153304 1k 3014421917 1k 3009157666 1k 3014164734 1k 3012104670 1k 3015997711 1k + More FDA FEI Numbers

Regulation

Us FDA 9k Eu Mdd 208 Eu Mdr 188 Eu Ivdr 3 Eu Ivdd 1 + More Regulations

Authorized Representative

Ar Experts B.V. 118 Certification Experts 118 Mym Soporte Tecnico Y De Calidad, S.L. 89 Medicom Gmb H 64 Cmc Medical Devices & Drugs Sl 25 Qb D Rep S Bv 19 Med Net Ec Rep Gmb H 16 Obelis S.A. 15 Advena Limited 8 Lotus Nl B.V. 6 Humiss Beratung Gmb H 4 Idd International Dental Distributors Ag 3 Sunoptic Europe 3 Psephos Limited 2 Shanghai International Holding Corp. Gmb H(europe) 2 3 A Composites Gmb H 1 Ajw Technology Consulting Gmb H 1 Beckman Coulter Ireland Inc. 1 Emergo Europe B.V. 1 Mdss Gmb H 1 + More Authorized Representatives

FDA Registration Number

3010220595 1k 8041005 1k 3012421607 1k 3013557562 1k 8040614 1k 3011200663 1k 3009538921 1k 3008253024 1k 3006367442 1k 1417592 1k 1423537 1k 3010175289 1k 3020521811 1k 3012441043 1k 3014421917 1k 8041003 1k 3014164734 1k 3012104670 1k 3015997711 1k 2648727 1k + More FDA Registration Numbers

FDA K Number

K033155 1 K051433 1 K072290 1 K082657 1 K201560 1 K210365 1 K210666 1 K212519 1 K213353 1 K213795 1 K220928 1 K221921 1 K222746 1 K223133 1 K223811 1 K230085 1 K230144 1 K231001 1 K231678 1 K231805 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 157 Mdd Annex V 20 Mdd Annex Ii Section 4 13 Mdr Qms 1 + More Certificate Types

Status

On The Market 159 Not Intended For Eu Market 1 + More Statuses

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

<1 …484 485 486 487 488 >

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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