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8,681 results · 41ms · Sources: EU EUDAMED, US FDA

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FDA UDI 4k FDA Pre-Market Approval 2k FDA registration 2k FDA 510(k) 877 Device 228 Basic UDI-DI 202 FDA classification 9 Manufacturer 4 Authorized representative 2 Importer 2 + More Filters

Country

United States 7k China 825 Germany 221 Hong Kong 206 United Kingdom 83 Canada 63 Taiwan 55 Mexico 41 Japan 31 Switzerland 25 Italy 24 France 21 South Korea 20 Netherlands 15 Thailand 14 Vietnam 12 Finland 10 India 9 Ireland 7 Pakistan 6 + More Countries

Manufacturer

Transatlantic Hg Stolpe & Co. Mb H 59 Maccura Biotechnology Co., Ltd. 45 Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. 44 Hangzhou Alltest Biotech.Co.,Ltd. 25 Abon Biopharm(hangzhou) Co., Ltd 14 Biochemical Diagnostics, Inc 12 Xiamen Biotime Biotechnology Co., Ltd. 12 Atlas Medical Gmb H 10 Hangzhou Cybereagen Biotech Co., Ltd. 8 Nano Diagnosis For Health Biotech (Guangzhou) Co., Ltd 8 Shenzhen Superbio Technology Co.,Ltd. 8 Wallac Oy 8 Sansure Biotech Inc. 7 Abiores Technology (Beijing) Co.,Ltd. 6 Accu Bio Tech Co., Ltd. 6 Atlas Link Technology Co., Ltd. 6 C Luminary Biotechnology Co., Ltd. 6 Cofoe Medical Technology Co.,Ltd. 6 Gaobeidian Prises Biotechnology Co., Ltd 6 Getein Biotech, Inc. 6 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 154 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 60 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 35 Agencia Española De Medicamentos Y Productos Sanitarios 31 De/Ca22 Bezirksregierung Münster 27 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 20 Federal Agency For Medicines And Health Products / / Health Products Division 17 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 14 Malta Medicines Authority 12 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 10 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 10 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 6 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 6 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 6 De/Ca304 Marktüberwachung Medizinprodukte Bayern 5 Turkish Medicine And Medical Devices Agency 5 Danish Medicines Agency, Pharmacovigilance & Medical Devices 4 State Institute For Drug Control Medical Device Section 3 The Medicines And Healthcare Products Regulatory Agency 3 De/Ca38 Regierungspräsidium Karlsruhe 2 + More Competent Authorities

Kind

Kit 170 Reagent 170 Professional Testing 154 Single Use 145 Animal Tissues 134 Self Testing 44 Human Tissues 25 Near Patient Testing 25 Microbial Substances 15 Companion Diagnostics 10 Instrument 2 Reusable 1 Sterile 1 Sterilization 1 + More Kinds

Classification

FDA Class 3 2k FDA Class 2 1k Eu Ivd General 258 FDA Class 1 138 Eu Ivd Self Testing 84 Eu Md Class 1 63 Eu Ivd Class B 9 Eu Ivd Annex 2 List B 8 Eu Ivd Class C 6 Eu Ivd Class A 2 + More Classifications

Notified Body

Tüv Süd Product Service Gmb H 61 Tüv Rheinland Lga Products Gmb H 21 Eurofins Electric & Electronics Finland Oy 8 Polskie Centrum Badan I Certyfikacji S.A. 2 + More Notified Bodies

FDA FEI Number

1317628 2k 1281950 2k 3002808845 2k 2011171 2k 3002807314 2k 3002807944 2k 1211998 2k 2246552 2k 2648045 2k 1000306431 2k 1038833 2k 1119279 2k 1119421 2k 1610287 2k 2648035 2k 3001284430 2k 3001659659 2k 3002808262 2k 3004651700 2k 3007530141 2k + More FDA FEI Numbers

Regulation

Us FDA 8k Eu Ivdd 350 Eu Mdr 63 Eu Ivdr 17 + More Regulations

Authorized Representative

Cmc Medical Devices & Drugs Sl 113 Shanghai International Holding Corp. Gmb H(europe) 96 Lotus Nl B.V. 84 Humiss International B.V. 45 C Epartner4 U 44 Med Net Ec Rep Gmb H 33 Sungo Cert Gmb H 25 Medunion S.L. 21 Osen Gmb H 21 Riomavix Ltd 21 Medical Technology Promedt Consulting Gmb H 20 Sungo Europe B.V. 20 Advena Limited 12 Wellkang Ltd 10 Qb D Rep S Bv 8 Med Path Gmb H 7 Obelis S.A. 7 Umedwings Netherlands B.V. 7 Luxus Lebenswelt Gmb H 6 Mdss Gmb H 6 + More Authorized Representatives

FDA Registration Number

1313525 2k 1281950 2k 9681630 2k 2011171 2k 3002807314 2k 9681121 2k 1211998 2k 2246552 2k 2648045 2k 1038833 2k 1063199 2k 1119279 2k 1119421 2k 1610287 2k 2029275 2k 2648035 2k 3007530141 2k 3010155661 2k 3012236936 2k 3015456951 2k + More FDA Registration Numbers

FDA K Number

K001215 1 K002049 1 K003856 1 K010522 1 K010593 1 K011550 1 K011551 1 K012215 1 K012284 1 K012559 1 K012579 1 K012698 1 K012943 1 K013194 1 K013372 1 K013702 1 K013907 1 K020128 1 K020378 1 K020438 1 + More FDA K Numbers

Certificate Type

Ivdd Annex Iv (Excluding Sections 4, 6) 90 Ivdd Annex Iii Section 6 2 + More Certificate Types

Status

On The Market 225 No Longer On The Market 3 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …431 432 433 434 435 >

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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