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BEUDAMED

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7,001 results · 45ms · Sources: EU EUDAMED, US FDA

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FDA UDI 6k FDA registration 444 FDA 510(k) 154 Device 143 Basic UDI-DI 124 FDA Pre-Market Approval 51 Importer 14 FDA classification 9 Manufacturer 8 Authorized representative 7 Certificate 3 + More Filters

Country

United States 6k China 261 Denmark 223 Japan 87 Gibraltar 30 Germany 26 France 19 Finland 16 United Kingdom 9 India 8 Costa Rica 7 South Korea 7 Hong Kong 5 Ireland 4 Netherlands 4 Hungary 3 Israel 3 Spain 3 Canada 2 Italy 2 + More Countries

Manufacturer

Bgi Europe A/S 220 Quies Sas 16 Cgi Suomi Oy 12 Gi Supply, Inc. 8 Xukang Medical Technology (Suzhou) Co., Ltd. 8 Wuhan Bgi Biomedical Engineering Co., Ltd. 6 Magstim Inc. 4 Taewoong Medical Co., Ltd. 4 Anhui Tiankang Medical Technology Co., Ltd. 3 Changsha Sinocare Inc. 3 Henan Yadu Industrial Co., Ltd 3 Qingdao Mgi Tech Co.,Ltd. 3 Sta Rmed Co., Ltd. 3 Wuhan Mgi Tech Co., Ltd. 3 Alton (Shanghai) Medical Instruments Co., Ltd. 2 Anrei Medical (Hz) Co., Ltd. 2 Beijing Demax Medical Technology Co.,Ltd. 2 Beijing Honghugaoxiang Science And Technology Development Co.,Ltd. 2 Changzhou Intl. Trade & Enterprises Cooperative Co.,Ltd. 2 Dong Guan City Good Health Electronic Technology Co., Ltd. 2 + More Manufacturers

Competent Authority

Danish Medicines Agency, Pharmacovigilance & Medical Devices 223 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 19 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 14 De/Ca304 Marktüberwachung Medizinprodukte Bayern 9 Federal Agency For Medicines And Health Products / / Health Products Division 9 De/Ca36 Regierungspräsidium Gießen Abteilung Ii Dezernat 25.1 Arbeitsschutz Gießen I 5 Ministry Of Health, Welfare And Sports 4 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 2 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 State Agency Of Medicines Medical Devices Evaluation Department 2 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 1 National Agency For Medicines And Medical Devices Of Romania 1 National Organisation For Medicines 1 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 1 State Health Care Accreditation Agency Under The Ministry Of Health Of The Republic Of Lithuania 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 + More Competent Authorities

Kind

Professional Testing 105 Single Use 97 Kit 91 Reagent 87 Near Patient Testing 62 Animal Tissues 59 Instrument 11 Software 11 Active 10 Human Tissues 1 Microbial Substances 1 Self Testing 1 + More Kinds

Classification

Eu Ivd General 154 FDA Class 2 115 Eu Ivd Class A 79 FDA Class 1 51 FDA Class 3 45 Eu Md Class 1 21 Eu Md Class 2b 6 Eu Md Class 2a 5 Eu Ivd Self Testing 2 FDA Unclassified 2 + More Classifications

Notified Body

Eurofins Electric & Electronics Finland Oy 7 Dekra Certification B.V. 4 Polskie Centrum Badan I Certyfikacji S.A. 4 Sgs Belgium Nv 1 + More Notified Bodies

FDA FEI Number

3014769442 73 1000122656 72 1000121056 71 3005099803 71 3002806565 70 3013557562 70 2246552 69 3004837686 69 3013440400 69 3012494290 68 3010273872 66 3010288205 66 3010605677 66 3037966040 66 1000393132 65 3002807795 65 3007695959 65 3000203000 64 3006696607 64 3008720584 64 + More FDA FEI Numbers

Regulation

Us FDA 7k Eu Ivdd 156 Eu Ivdr 79 Eu Mdd 21 Eu Mdr 11 + More Regulations

Authorized Representative

Med Path Gmb H 8 Qb D Rep S Bv 8 Share Info Gmb H 7 Mps Medical Product Service Gmb H 4 Latvia Mgi Tech Sia 1 Pure Ce B.V. 1 Sungo Europe B.V. 1 Shanghai International Holding Corp. Gmb H(europe) 1 Yyuka International Gb R 1 + More Authorized Representatives

FDA Registration Number

3014769442 73 1528319 72 1000121056 71 3005099803 71 3013557562 70 9681260 70 2246552 69 3004837686 69 3013440400 69 3012494290 68 3010273872 66 3010288205 66 3010605677 66 3037966040 66 1000393132 65 3007695959 65 3011050570 65 1061927 64 3006696607 64 3008720584 64 + More FDA Registration Numbers

FDA K Number

K000646 1 K001146 1 K002323 1 K002573 1 K002778 1 K010448 1 K011484 1 K011759 1 K012977 1 K013712 1 K013889 1 K021179 1 K022484 1 K023603 1 K023903 1 K030451 1 K031238 1 K033754 1 K040137 1 K042615 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 11 Ivdd Annex Iii Section 6 4 Mdr Qms 2 + More Certificate Types

Status

On The Market 143 + 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

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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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