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BEUDAMED

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7,881 results · 43ms · Sources: EU EUDAMED, US FDA

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FDA UDI 4k FDA registration 2k FDA 510(k) 582 FDA Pre-Market Approval 438 Device 407 Basic UDI-DI 32 Importer 12 Authorized representative 9 FDA classification 8 Certificate 5 Manufacturer 5 + More Filters

Country

United States 6k Switzerland 578 China 516 South Korea 359 Germany 228 Vietnam 150 Mexico 142 Türkiye 74 Brazil 49 Hong Kong 38 Italy 33 Canada 31 Taiwan 26 Singapore 17 United Kingdom 16 France 10 Belgium 8 India 8 Japan 8 Slovakia 8 + More Countries

Manufacturer

Shenzhen Antmed Co., Ltd 302 Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.Ltd. şti̇ 68 Alliage S/A Indústrias Médico Odontológica 47 Hangzhou Genesis Biodetection And Biocontrol Co., Ltd. 9 Zesa Tıbbi Cihazlar Med. Kim. San. Tic. Ltd. şti 4 Ntc Srl 3 Ningbo Greatcare Medical Instruments Co.,Ltd 3 Beijing Delta Medical Science & Technology Corp. Ltd. 2 Beijing Globalipl Development Co., Ltd 2 Chien Ti Enterprise Co., Ltd. 2 Chungwoo Co., Ltd. 2 Cytocell Limited 2 Dirui Industrial Co., Ltd 2 Genejet Biotech Co., Ltd. 2 Gentec (Shanghai) Corporation 2 Guangzhou Daoke Biomedical Technology Co.,Ltd., 2 Guangzhou Phoenix Medical Equipment Co., Ltd. 2 Guilin Kevin Peter Technology Co., Ltd. 2 Guilin Refine Medical Instrument Co.,Ltd. 2 Guilin Woodpecker Medical Instrument Co., Ltd. 2 + More Manufacturers

Competent Authority

De/Ca22 Bezirksregierung Münster 297 Turkish Medicine And Medical Devices Agency 75 Infarmed – National Authority Of Medicines And Health Products, I.P 48 Ministry Of Health, Welfare And Sports 15 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 6 De/Ca21 Bezirksregierung Köln Dezernat 24 5 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 3 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 3 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 2 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 2 De/Ca304 Marktüberwachung Medizinprodukte Bayern 2 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 2 Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia: Medical Devices Division / Pharmaceutical Inspection Division – Medical Devices Unit 1 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 1 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 1 Malta Medicines Authority 1 State Agency Of Medicines Medical Devices Evaluation Department 1 + More Competent Authorities

Kind

Single Use 360 Sterile 289 Professional Testing 8 Reagent 7 Kit 5 Reprocessed 5 Active 2 Implantable 2 Administering Medicine 1 Animal Tissues 1 Human Tissues 1 Instrument 1 Measuring Function 1 Microbial Substances 1 + More Kinds

Classification

FDA Class 2 560 FDA Class 3 424 Eu Md Class 1 180 Eu Md Class 2a 132 Eu Md Class 2b 103 FDA Class 1 37 Eu Ivd Class A 11 Eu Md Class 3 5 Eu Ivd General 4 FDA Unclassified 4 Eu Ivd Class C 3 Eu Ivd Class B 1 FDA Not Classified 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 4 Italcert Srl 3 Dnv Medcert Gmb H 1 Istituto Superiore Di Sanita' 1 Tüv Rheinland Lga Products Gmb H 1 + More Notified Bodies

FDA FEI Number

2011171 422 3002807314 396 3004091615 394 3004635528 394 2183744 310 2124215 302 2024168 297 3002806565 297 2024024 295 3010432890 294 1643817 293 1016427 289 1219930 289 2183870 289 3002807036 289 3003473227 289 3003528016 289 3003956144 289 3007215228 289 3010079067 289 + More FDA FEI Numbers

Regulation

Us FDA 7k Eu Mdr 415 Eu Ivdr 15 Eu Mdd 5 Eu Ivdd 4 + More Regulations

Authorized Representative

Med Net Ec Rep Gmb H 295 Med Net Ec Rep C I Ib Gmb H 294 Cinterqual Soluções De Comércio Internacional,Lda. 47 Els Solutions Gdia Unipessoal Lda. 47 Cmc Medical Devices & Drugs Sl 9 Lotus Nl B.V. 9 Greatcare Medical Gmb H 3 Emergo Europe B.V. 2 Medical Technology Promedt Consulting Gmb H 2 Shanghai International Holding Corp. Gmb H(europe) 2 Sysmex Europe Gmb H 2 Sysmex Europe Se 2 Nta Implant Grup Sanayi̇ Ti̇caret Anoni̇m şi̇rketi̇ 1 Riomavix Ltd 1 Sungo Europe B.V. 1 + More Authorized Representatives

FDA Registration Number

2011171 422 3002807314 396 2939561 394 3004091615 394 2183744 310 2124215 302 2024168 297 9681260 297 2024024 295 3010432890 294 1643817 293 1016427 289 1219930 289 1424778 289 2183870 289 3003956144 289 3010079067 289 3010173425 289 3011471056 289 3013556777 289 + More FDA Registration Numbers

FDA K Number

K000379 1 K001138 1 K001787 1 K002026 1 K002493 1 K002846 1 K003927 1 K011804 1 K012271 1 K012842 1 K013084 1 K014071 1 K014115 1 K021328 1 K021390 1 K021442 1 K021446 1 K021716 1 K022071 1 K023494 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii Section 4 5 Mdr Qms 3 Mdd Annex V 1 Mdr Qa 1 + More Certificate Types

Status

On The Market 404 No Longer On The Market 2 Not Intended For Eu Market 1 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …391 392 393 394 395 >

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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