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BEUDAMED

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4,941 results · 44ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 1k Device 602 FDA 510(k) 347 Basic UDI-DI 65 FDA Pre-Market Approval 21 FDA classification 16 Manufacturer 10 Importer 7 Authorized representative 5 Certificate 2 System producer 1 + More Filters

Country

United States 3k China 805 Germany 201 Taiwan 165 Hong Kong 104 Malaysia 69 Switzerland 64 Mexico 46 Italy 44 Canada 24 Spain 24 France 19 South Korea 15 Philippines 13 Indonesia 11 United Kingdom 11 Ireland 8 India 6 Israel 6 Denmark 5 + More Countries

Manufacturer

Astar Orthodontics Inc. 350 Kirchner & Wilhelm Gmb H + Co Kg 120 Operating Theatre Medical (Zhijiang) Co., Ltd 110 Iso Med 13 Maccura Biotechnology Co., Ltd. 13 Atlas Medical Gmb H 12 Beckman Coulter Inc. 8 Ningbo Flo Optical Technology Development Co.,Ltd. 7 Medicon Hellas Sa 6 Aso Llc 4 C.P.M. Compagnia Per La Medicina S.R.L. 4 Genrui Biotech Inc. 4 Harps Investment Asia Pte. Ltd. 3 Microcopy, A Division Of Neo Flo, Inc. 3 Shanghai Iso Medical Products Co., Ltd. 3 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 3 Winner Medical Co., Ltd. 3 Angelus Indústria De Produtos Odontológicos S/A 2 Changsha Sinocare Inc. 2 Formed Pro Spółka Z Ograniczoną Odpowiedzialnością 2 + More Manufacturers

Competent Authority

Infarmed – National Authority Of Medicines And Health Products, I.P 350 De/Ca37, Regierungspräsidium Stuttgart 120 Federal Agency For Medicines And Health Products / / Health Products Division 119 Ministry Of Health, Welfare And Sports 35 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 17 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 12 Health Products Regulatory Authority, Medical Devices Department 10 National Organisation For Medicines 6 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 5 Agencia Española De Medicamentos Y Productos Sanitarios 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 3 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 3 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 3 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 2 De/Ca11 Staatliches Gewerbeaufsichtsamt Oldenburg Dezernat Gesundheitswesen, Medizinprodukte Und Strahlenschutz 1 De/Ca40 Regierungspräsidium Tübingen Referat 25 Sachgebiet Medizinprodukte 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 + More Competent Authorities

Kind

Single Use 457 Sterilization 88 Professional Testing 36 Reagent 33 Kit 32 Animal Tissues 23 Sterile 9 Human Tissues 8 Active 5 Administering Medicine 3 Companion Diagnostics 2 Reusable 2 Latex 1 Measuring Function 1 Microbial Substances 1 Near Patient Testing 1 + More Kinds

Classification

Eu Md Class 2a 370 Eu Md Class 1 237 FDA Class 2 194 FDA Class 1 159 Eu Ivd General 45 FDA Class 3 17 Eu Ivd Class B 11 FDA Unclassified 8 Eu Ivd Class C 2 Eu Md Class 2b 2 FDA Not Classified 1 + More Classifications

Notified Body

Ht Cert (Health Technology Certification Ltd) 13 Eurofins Electric & Electronics Finland Oy 2 Tüv Rheinland Lga Products Gmb H 2 + More Notified Bodies

FDA FEI Number

1417592 168 1043214 150 3026408938 149 3005011024 133 3003737899 126 3016761372 126 1000306431 106 1000138054 104 3005747797 98 1000512168 97 1643817 97 1018470 95 3012307300 95 3010131137 93 3012421607 92 3013557562 92 3009746061 91 3012104670 91 3015997711 91 3000206435 90 + More FDA FEI Numbers

Regulation

Us FDA 4k Eu Mdr 595 Eu Ivdd 45 Eu Mdd 14 Eu Ivdr 13 + More Regulations

Authorized Representative

Bio Concept, Unipessoal, Lda 350 Mono Uso Nv 114 Shanghai International Holding Corp. Gmb H(europe) 20 Lotus Nl B.V. 16 Cmc Medical Devices & Drugs Sl 15 Humiss International B.V. 13 Beckman Coulter Ireland Inc. 8 Osen Gmb H 6 Aso Europe Bv 4 Medunion S.L. 2 Qb D Rep S Bv 2 Sungo Europe B.V. 2 Sungo Cert Gmb H 2 Cs Life Sciences Europe Ltd 1 Obelis S.A. 1 + More Authorized Representatives

FDA Registration Number

1417592 168 1043214 150 3026408938 149 3005011024 133 3016761372 126 9680794 126 2029275 105 1319639 104 1643817 98 3011137372 98 1061124 97 1018470 95 3012307300 95 3010131137 93 3012421607 92 3013557562 92 3009746061 91 3012104670 91 3015997711 91 1423507 90 + More FDA Registration Numbers

FDA K Number

K000886 1 K001717 1 K011800 1 K012685 1 K022019 1 K023140 1 K023233 1 K024011 1 K032002 1 K032390 1 K033593 1 K042488 1 K043456 1 K050136 1 K050557 1 K051401 1 K051524 1 K062005 1 K063234 1 K070465 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 15 Mdr Qms 2 + More Certificate Types

Status

On The Market 602 + More Statuses

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 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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