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BEUDAMED

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3,041 results · 32ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA registration 613 FDA 510(k) 112 Device 53 Basic UDI-DI 15 FDA Pre-Market Approval 6 Importer 4 Authorized representative 3 FDA classification 3 Manufacturer 3 + More Filters

Country

United States 3k China 90 South Korea 78 Canada 50 India 45 Indonesia 39 United Kingdom 25 Poland 13 Thailand 13 Taiwan 12 Netherlands 11 Germany 8 Portugal 5 Hong Kong 4 Spain 3 Türkiye 3 Cambodia 1 Denmark 1 Ireland 1 Jordan 1 + More Countries

Manufacturer

Jc Orthoheal Private Limited 46 A. J. Costa (Irmãos), Lda. 5 Aga Sanitätsartikel Gmb H 5 Sansure Biotech Inc. 5 Graso Zenon Sobiecki 3 1922 Pty Ltd 1 20/20 Medical Systems, Inc. 1 A & I Industries Ltd Shunde Foshan 1 Aaruy Medical (Guangdong) Co., Ltd. 1 Aaruy Medical Electronics Co., Ltd. 1 Across Industrial Co.,Ltd 1 Afzal Saeed Manufacturing Corp 1 Aigene Co., Ltd. 1 Allmed Medical Textile Co.,Ltd (Viet Nam) 1 Anhui Bytech Medical Supplies Co., Ltd. 1 Anhui Guohong Industrial And Trading Co.,Ltd 1 Anhui Kaiigo Intelligent Technology Co.,Ltd. 1 Anhui Konzern Package Material Co.,Ltd 1 Anji Jixiang Medical Co.,Ltd 1 Anji Yaohui Medical Products Co., Ltd. 1 + More Manufacturers

Competent Authority

Agencia Española De Medicamentos Y Productos Sanitarios 48 Federal Agency For Medicines And Health Products / / Health Products Division 6 De/Ca19 Bezirksregierung Detmold Dezernat 24 5 Infarmed – National Authority Of Medicines And Health Products, I.P 5 Ministry Of Health, Welfare And Sports 3 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 3 Turkish Medicine And Medical Devices Agency 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca21 Bezirksregierung Köln Dezernat 24 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 State Agency Of Medicines Medical Devices Evaluation Department 1 + More Competent Authorities

Kind

Single Use 41 Professional Testing 11 Reagent 11 Microbial Substances 8 Kit 7 Animal Tissues 4 Companion Diagnostics 3 Active 1 + More Kinds

Classification

FDA Class 2 81 Eu Md Class 1 52 FDA Class 1 33 Eu Ivd General 6 FDA Class 3 6 Eu Md Class 2a 5 Eu Ivd Class A 4 Eu Ivd Class B 1 FDA Unclassified 1 + More Classifications

FDA FEI Number

1832216 246 3006305917 65 1000306617 64 3005670738 60 3000210620 59 3003917514 56 3001452245 51 1000442352 49 3015550354 49 3004987297 47 3008852306 47 3006798115 46 3005984081 45 3012725363 45 3021186226 45 3009585529 44 3013679502 44 3024463179 44 2246703 43 3003102569 43 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdr 57 Eu Ivdd 6 Eu Ivdr 5 + More Regulations

Authorized Representative

Af Pharma Service Europe Sl 45 Lotus Nl B.V. 6 Obelis S.A. 6 Osen Gmb H 5 Kerr Italia Srl 1 Riomavix Ltd 1 Sungo Europe B.V. 1 Shanghai International Holding Corp. Gmb H(europe) 1 + More Authorized Representatives

FDA Registration Number

1832216 246 3006305917 65 2029372 64 3005360469 60 2030633 59 3003917514 56 2060833 51 1063851 49 3015550354 49 3004987297 47 3008852306 47 3004635103 46 3006798115 46 3005984081 45 3012725363 45 3021186226 45 3009585529 44 3013679502 44 3024463179 44 2087033 43 + More FDA Registration Numbers

FDA K Number

K001356 1 K002265 1 K002587 1 K010226 1 K011185 1 K013180 1 K022141 1 K022388 1 K022501 1 K031497 1 K053033 1 K060355 1 K060896 1 K080347 1 K132630 1 K161044 1 K171403 1 K180878 1 K181305 1 K240287 1 + More FDA K Numbers

Status

On The Market 53 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …149 150 151 152 153 >

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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