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BEUDAMED

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3,021 results · 39ms · Sources: EU EUDAMED, US FDA

Filter by

Device 995 FDA registration 910 FDA UDI 780 FDA Pre-Market Approval 232 FDA 510(k) 78 Basic UDI-DI 15 FDA classification 5 Authorized representative 3 Manufacturer 3 + More Filters

Country

United States 2k Germany 231 United Kingdom 228 China 117 Belgium 34 Malaysia 11 Ireland 9 Italy 9 Netherlands 9 Denmark 7 Hong Kong 7 Slovakia 7 Australia 6 Taiwan 6 India 4 Pakistan 4 Türkiye 4 Canada 3 France 3 Spain 3 + More Countries

Manufacturer

Becker Orthopedic Appliance Company 616 P W Coole & Son Ltd T/A Surgical Holdings 369 Passy Muir, Inc. 10 Vitrosens Biyoteknoloji Anonim şirketi 4 Xiamen Biotime Biotechnology Co., Ltd. 4 Shanghai Zymetas Medtech Co., Ltd 3 Sejoy Biomedical Co., Ltd. 2 Pointimplant Co., Ltd. 1 Senbitec Co Ltd 1 Aadhar Medicare Private Limited 1 Ac Cossor And Son (Surgical) Ltd 1 Ace Medical Devices Pvt Ltd 1 Afzal Saeed Manufacturing Corp 1 Airs Medical Inc. 1 Angstrom Biotech Pvt. Ltd. 1 Aon Co.,Ltd 1 Apex Pulp Sdn.Bhd 1 Aqualution Systems Ltd 1 Arc Microtech Ltd 1 Arthro Dynamik Ltd 1 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 618 Malta Medicines Authority 371 Ministry Of Health, Welfare And Sports 17 Turkish Medicine And Medical Devices Agency 4 Agencia Española De Medicamentos Y Productos Sanitarios 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 2 The Medicines And Healthcare Products Regulatory Agency 1 + More Competent Authorities

Kind

Sterilization 367 Kit 9 Professional Testing 9 Reagent 9 Single Use 6 Near Patient Testing 5 Companion Diagnostics 2 + More Kinds

Classification

Eu Md Class 1 985 FDA Class 3 230 FDA Class 2 63 FDA Class 1 20 Eu Ivd General 14 Eu Md Class 2a 10 Eu Ivd Class A 1 FDA Unclassified 1 + More Classifications

Notified Body

National Standards Authority Of Ireland (Nsai) 10 + More Notified Bodies

FDA FEI Number

3004493545 205 2011171 173 1721676 172 2020394 172 1721504 171 1721686 171 2017233 171 3002504068 171 3002806368 171 3002807111 171 3003094851 171 3006950086 171 3012536737 171 3015309643 171 3033589330 171 3006272282 126 1119279 46 1317628 46 1610287 46 3002807944 46 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Mdr 985 Eu Ivdd 14 Eu Mdd 10 Eu Ivdr 1 + More Regulations

Authorized Representative

Acorn Regulatory Consultancy Services Ltd 616 Advena Limited 370 Emergo Europe B.V. 10 Shanghai International Holding Corp. Gmb H(europe) 6 Lotus Nl B.V. 5 Medunion S.L. 5 Osen Gmb H 4 Sungo Cert Gmb H 4 Sungo Europe B.V. 3 Cmc Medical Devices & Drugs Sl 2 Af Pharma Service Europe Sl 1 Eurolink Europe Compliance Limited 1 Luxus Lebenswelt Gmb H 1 Wellkang Ltd 1 + More Authorized Representatives

FDA Registration Number

3004493545 205 2011171 173 1721676 172 2020394 172 1721504 171 1721686 171 1724474 171 2017233 171 3002504068 171 3005941719 171 3006950086 171 3012536737 171 3015309643 171 3033589330 171 9681442 171 3006272282 126 1119279 46 1313525 46 1610287 46 9681121 46 + More FDA Registration Numbers

FDA K Number

K014124 1 K102473 1 K122367 1 K131002 1 K133011 1 K153069 1 K153605 1 K162478 1 K192385 1 K222212 1 K233881 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 10 + More Certificate Types

Status

On The Market 995 + More Statuses

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices

<1 …148 149 150 151 152 >

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

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

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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