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BEUDAMED

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9,501 results · 51ms · Sources: EU EUDAMED, US FDA

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FDA UDI 7k FDA registration 2k FDA 510(k) 216 FDA Pre-Market Approval 160 Device 57 Basic UDI-DI 43 Importer 15 FDA classification 11 Authorized representative 6 Manufacturer 5 Certificate 2 + More Filters

Country

United States 7k China 880 Germany 465 Mexico 214 India 123 Malaysia 82 Indonesia 58 Canada 57 Pakistan 57 Taiwan 48 Türkiye 45 Italy 40 South Korea 37 United Kingdom 35 Ireland 34 Japan 30 Israel 26 Hungary 13 Thailand 12 Hong Kong 10 + More Countries

Manufacturer

Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 37 Batrik Medical Manufacturing Inc. 25 Xuzhou Akx Electronic Science And Technology Co.，Ltd 21 Kai Industries Co., Ltd. 12 Bioxol Kft 6 Kay Pictures 5 Lang Stereotest Ag 4 Bionix Llc 3 Contec Medical Systems Co., Ltd. 3 Keeler Ltd 3 Shenzhen Certainn Technology Co., Ltd. 3 A&D Company, Limited 2 Apacor Limited 2 Amplivox Limited 2 Beijing Datsing Bio Tech Co., Ltd. 2 Cu Medical Systems, Inc. 2 Edan Instruments,Inc. 2 Fabrication Enterprises 2 Fabrinal Sa 2 Foosin Medical Supplies Inc., Ltd. 2 + More Manufacturers

Competent Authority

Turkish Medicine And Medical Devices Agency 40 Malta Medicines Authority 25 Ministry Of Health, Welfare And Sports 22 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 12 Federal Agency For Medicines And Health Products / / Health Products Division 6 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 6 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 4 De/Ca22 Bezirksregierung Münster 3 Agencia Española De Medicamentos Y Productos Sanitarios 2 National Agency For Medicines And Medical Devices Of Romania 2 Austrian National Public Health Institute 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca19 Bezirksregierung Detmold Dezernat 24 1 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 1 Health Products Regulatory Authority, Medical Devices Department 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 + More Competent Authorities

Kind

Single Use 29 Cmr Substance 6 Sterile 6 Professional Testing 5 New Device 4 Reagent 4 Active 3 Animal Tissues 2 Instrument 1 Kit 1 + More Kinds

Classification

FDA Class 2 146 FDA Class 3 100 FDA Class 1 96 Eu Md Class 1 84 FDA Unclassified 42 Eu Md Class 2a 7 Eu Ivd Class A 6 Eu Ivd Class B 2 Eu Ivd General 1 FDA Not Classified 1 + More Classifications

Notified Body

Sgs Belgium Nv 24 Tüv Rheinland Lga Products Gmb H 2 Dqs Medizinprodukte Gmb H 1 + More Notified Bodies

FDA FEI Number

3002807464 205 3003058448 180 1000306431 171 3007648354 164 3018094310 149 3002807391 147 1643817 121 1928237 121 1450662 113 2648623 98 3005334138 91 2183744 88 2124215 87 2245304 86 2182208 84 2649622 84 3012552532 84 3004105270 81 3009504230 81 3009380063 80 + More FDA FEI Numbers

Regulation

Us FDA 9k Eu Mdr 66 Eu Mdd 25 Eu Ivdr 8 Eu Ivdd 1 + More Regulations

Authorized Representative

Advena Limited 25 Sungo Europe B.V. 20 Kai Europe Gmb H 9 Shanghai International Holding Corp. Gmb H(europe) 2 Beckman Coulter Ireland Inc. 1 Cmc Medical Devices & Drugs Sl 1 Lotus Nl B.V. 1 Med Net Ec Rep C Iii Gmb H 1 Obelis S.A. 1 Qb D Rep S Bv 1 + More Authorized Representatives

FDA Registration Number

9610905 205 2032098 180 2029275 171 3007648354 164 3018094310 149 9610849 147 1643817 121 1928237 121 1450662 113 2648623 98 2183744 88 2124215 87 2245304 86 2182208 84 2649622 84 3005334138 84 3012552532 84 3004105270 81 3009504230 81 3009380063 80 + More FDA Registration Numbers

FDA K Number

K000021 1 K013993 1 K020009 1 K024372 1 K041363 1 K043260 1 K050292 1 K050440 1 K052528 1 K060987 1 K063330 1 K082491 1 K091121 1 K091636 1 K102071 1 K102762 1 K103822 1 K111524 1 K111538 1 K111575 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 25 Mdr Qms 2 + More Certificate Types

Status

On The Market 57 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …472 473 474 475 476 >

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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