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BEUDAMED

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3,541 results · 37ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA registration 827 Basic UDI-DI 252 FDA 510(k) 218 Device 100 FDA Pre-Market Approval 32 Importer 10 FDA classification 6 Manufacturer 5 Authorized representative 3 Certificate 1 + More Filters

Country

United States 2k China 282 Indonesia 227 Pakistan 137 Germany 90 Switzerland 83 Italy 73 Slovakia 62 Mexico 43 India 24 United Kingdom 17 Malaysia 13 South Korea 10 France 7 Canada 6 Netherlands 6 Spain 6 Ireland 5 Singapore 4 Finland 3 + More Countries

Manufacturer

Chongqing Fws Medical Device Co.,Ltd 163 Anhui Jbh Medical Apparatus Co., Ltd 100 Ibl International Gmb H 53 Cytocell Limited 6 Innomed, Inc. 5 Able Human Motion 4 Jiangsu Bioperfectus Technologies Co., Ltd. 4 Vela Operations Singapore Pte. Ltd. 4 Safeguard Medical Technologies Ltd. 3 Variteks Ortopedi Sanayi A.S. 3 Water Jel Technologies, Llc 3 Beijing Choice Electronic Technology Co., Ltd. 2 Blizzard Protection Systems Ltd 2 C A T Resources, Llc 2 Clinimed 2 First Care Products Ltd. 2 Gama Healthcare Ltd. 2 Hartwell Medical Llc 2 Intersurgical Ltd 2 Jiangsu Macro & Micro Test Med Tech Co., Ltd. 2 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 265 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 60 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 8 Agencia Española De Medicamentos Y Productos Sanitarios 6 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 6 Health Products Regulatory Authority, Medical Devices Department 5 De/Ca22 Bezirksregierung Münster 4 Federal Agency For Medicines And Health Products / / Health Products Division 3 Turkish Medicine And Medical Devices Agency 3 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 De/Ca38 Regierungspräsidium Karlsruhe 2 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 2 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 2 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Malta Medicines Authority 1 Ministère De La Santé Direction De La Santé Division De La Pharmacie Et Des Médicament Médical Devices Unit 1 + More Competent Authorities

Kind

Implantable 163 Orthopedic 163 Active 49 Reagent 34 Kit 33 Professional Testing 32 Single Use 32 Animal Tissues 25 Human Tissues 11 Sterilization 7 Microbial Substances 6 New Device 2 Reusable 1 + More Kinds

Classification

Eu Md Class 2b 163 FDA Class 2 115 FDA Class 1 113 Eu Md Class 1 112 Eu Ivd Class B 45 FDA Class 3 24 Eu Ivd General 17 Eu Ivd Class C 6 Eu Ivd Annex 2 List B 4 Eu Ivd Class A 3 FDA Unclassified 3 Eu Md Class 2a 2 + More Classifications

Notified Body

Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 163 Bsi Group The Netherlands B.V. 6 + More Notified Bodies

FDA FEI Number

3029082594 135 3013557562 89 3002166545 88 1928237 85 1417592 83 3012421607 79 3014680795 79 3012104670 75 3015997711 75 3014421917 73 1220477 71 3010131137 70 2648727 69 3007502227 68 2939388 67 3001236905 67 3003199637 67 3003529075 67 3011209798 67 1250045 65 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 163 Eu Mdr 114 Eu Ivdr 54 Eu Ivdd 21 + More Regulations

Authorized Representative

Kingsmead Service B.V. 163 Sungo Europe B.V. 98 Medi Mark Europe Sarl. 6 Shanghai International Holding Corp. Gmb H(europe) 6 Sysmex Europe Gmb H 6 Sysmex Europe Se 6 Lotus Nl B.V. 4 Med Net Ec Rep Gmb H 4 Vela Diagnostics Germany Gmb H 4 Antex Medi Solution 2 Cmc Medical Devices & Drugs Sl 2 Obelis S.A. 2 Riomavix Ltd 2 Wellkang Ltd 2 Advena Limited 1 Medical Device Management Ltd 1 Philips Medical Systems Nederland B.V. 1 Sungo Cert Gmb H 1 + More Authorized Representatives

FDA Registration Number

3029082594 135 3013557562 89 8040653 88 1928237 85 1417592 83 3012421607 79 3014680795 79 3012104670 75 3015997711 75 3014421917 73 1220477 71 3010131137 70 2648727 69 3007502227 68 1423537 67 2939388 67 3003199637 67 3003529075 67 3011209798 67 1250045 65 + More FDA Registration Numbers

FDA K Number

Den210039 1 K040898 1 K180202 1 K790211 1 K791996 1 K792610 1 K801960 1 K811260 1 K811261 1 K820088 1 K821576 1 K853571 1 K860147 1 K871194 1 K883915 1 K891098 1 K891099 1 K897171 1 K902237 1 K904181 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 163 Ivdd Annex Iv (Excluding Sections 4, 6) 6 + More Certificate Types

Status

On The Market 100 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

<1 …174 175 176 177 178 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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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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