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BEUDAMED

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7,601 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k Basic UDI-DI 2k Device 2k FDA registration 438 FDA 510(k) 119 Manufacturer 96 Certificate 37 Importer 35 FDA Pre-Market Approval 33 Authorized representative 9 System producer 4 FDA classification 3 + More Filters

Country

United States 3k China 3k Germany 909 Canada 134 Japan 66 Switzerland 42 Russian Federation 31 India 22 South Korea 20 Israel 15 Taiwan 15 Mexico 14 Pakistan 14 United Kingdom 14 Australia 9 Austria 6 Netherlands 6 Malaysia 5 United Arab Emirates 5 Italy 4 + More Countries

Manufacturer

Shenzhen Superbio Technology Co.,Ltd. 1k Quali Med Innovative Medizinprodukte Gmb H 792 Autobio Diagnostics Co., Ltd. 415 Zybio Inc. 359 Shanghai Kehua Bio Engineering Co., Ltd. 244 Amoy Diagnostics Co., Ltd. 115 Anhui Jbh Medical Apparatus Co., Ltd 99 Bpr Medical Limited 89 Bio Lytical Laboratories Inc. 81 In Tec Products, Inc. 54 Eiken Chemical Co., Ltd. 50 Xukang Medical Technology (Suzhou) Co., Ltd. 46 Dna Genotek Inc. 41 Yelatma Instrument Making Enterprise Joint Stock Company 30 Zhengzhou Bioyuan Biotech Co. Ltd. 24 Drucker Diagnostics 19 Hbh Biotechnology Limited 18 Mdt Int'l Sa 18 Medical & Biological Laboratories Co., Ltd. 14 23and Me, Inc. 13 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 3k De/Ca10 Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte 793 Ministry Of Health, Welfare And Sports 221 Malta Medicines Authority 50 Agencia Española De Medicamentos Y Productos Sanitarios 15 De/Ca18 Bezirksregierung Arnsberg 6 De/Ca304 Marktüberwachung Medizinprodukte Bayern 6 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 6 Health Products Regulatory Authority, Medical Devices Department 6 De/Ca24 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 5 Austrian National Public Health Institute 4 De/Ca21 Bezirksregierung Köln Dezernat 24 4 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 4 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 3 De/Ca22 Bezirksregierung Münster 3 De/Ca38 Regierungspräsidium Karlsruhe 3 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 2 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 2 + More Competent Authorities

Kind

Professional Testing 1k Reagent 1k Kit 1k Single Use 875 Animal Tissues 824 Implantable 581 Sterile 236 Human Tissues 234 Microbial Substances 91 Active 70 Administering Medicine 44 Instrument 42 New Device 27 Self Testing 20 Near Patient Testing 18 Companion Diagnostics 10 Software 9 Measuring Function 2 Medicinal Product 1 Reusable 1 + More Kinds

Classification

Eu Ivd General 2k Eu Md Class 2b 804 Eu Ivd Class A 360 Eu Ivd Class C 285 Eu Ivd Class B 221 Eu Md Class 1 135 Eu Ivd Annex 2 List A 90 Eu Md Class 2a 90 FDA Class 1 82 FDA Class 2 40 FDA Class 3 33 Eu Md Class 3 12 Eu Ivd Annex 2 List B 8 Eu Ivd Self Testing 8 + More Classifications

Notified Body

Dekra Certification Gmb H 792 Sgs Belgium Nv 92 Presafe Denmark A/S 74 Tüv Süd Product Service Gmb H 32 Tüv Nord Cert Gmb H 14 Dekra Certification B.V. 13 Polskie Centrum Badan I Certyfikacji S.A. 13 Bsi Group The Netherlands B.V. 12 Istituto Superiore Di Sanita' 7 Mdc Medical Device Certification Gmbh 6 Ce Cert Sp. Z O.O. 4 Slg Prüf Und Zertifizierungs Gmbh 2 + More Notified Bodies

FDA FEI Number

3002675176 80 1000306431 65 1043214 63 3002750084 63 1000512168 62 1000219637 61 3007208013 61 1216677 59 1526711 59 1000123222 57 3013188547 55 2027062 54 3005747797 54 3013298431 54 3008770252 53 3010131137 53 1018233 52 2182318 52 3001084824 52 3004829691 51 + More FDA FEI Numbers

Regulation

Us FDA 4k Eu Ivdd 2k Eu Mdd 907 Eu Ivdr 866 Eu Mdr 134 + More Regulations

Authorized Representative

Qb D Rep S Bv 3k Cmc Medical Devices & Drugs Sl 1k Lotus Nl B.V. 369 Shanghai International Holding Corp. Gmb H(europe) 362 Emergo Europe B.V. 144 Sungo Europe B.V. 97 Human Gesellschaft Für Biochemica Und Diagnostica Mb H 52 Advena Limited 50 Novosanis Nv 42 Kingsmead Service B.V. 20 Riomavix Ltd 10 Obelis S.A. 6 Meridius Medical Europe Limited 5 Aachen Resonance Entwicklungsgesellschft Für Magnetresonanz Kompatible Medizinprodukte Mb H 1 Geistlich Biomaterials Vertriebsgesellschaft Mb H 1 Pall Gene Disc Technologies 1 Radimed Gesellschaft Für Kommunikationsdienstleistungen Und Medizintechnik Mb H 1 Sgt Servicegesellschaft Technipack Mb H 1 Tsi Quality Services 1 Bio Mérieux Sa 1 + More Authorized Representatives

FDA Registration Number

3002675176 80 1043214 64 2029275 64 1061124 63 1836161 63 1058584 61 3007208013 61 1216677 59 1526711 59 1123071 57 3013188547 55 2027062 54 3011137372 54 3013298431 54 1018233 53 3008770252 53 3010131137 53 2182318 52 3004365956 51 3015058854 51 + More FDA Registration Numbers

FDA K Number

Den170047 1 K140097 1 K191967 1 K781695 1 K802601 1 K810737 1 K811185 1 K822794 1 K830706 1 K843790 1 K851874 1 K860845 1 K862084 1 K864526 1 K871560 1 K872277 1 K872832 1 K882079 1 K882694 1 K882891 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 906 Ivdd Annex Iv Section 4 106 Ivdd Annex Iv (Excluding Sections 4, 6) 94 Mdd Annex Ii Section 4 13 Ivdd Annex Iii Section 6 12 Mdd Annex V 4 Mdd Annex Iv 2 Mdr Qms 2 + More Certificate Types

Status

On The Market 2k No Longer On The Market 34 Not Intended For Eu Market 14 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

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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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