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BEUDAMED

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2,701 results · 36ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k FDA registration 778 FDA Pre-Market Approval 237 FDA 510(k) 193 Basic UDI-DI 34 Device 34 Authorized representative 5 FDA classification 4 Manufacturer 4 Importer 3 Certificate 1 + More Filters

Country

United States 2k Germany 138 Greece 67 United Kingdom 60 China 50 Netherlands 37 Canada 29 Mexico 28 Switzerland 27 Malaysia 18 Finland 14 South Korea 14 Italy 6 Spain 5 France 4 India 3 Japan 3 Singapore 3 Denmark 2 Israel 2 + More Countries

Manufacturer

Jr Engineering & Medical Technologies (M) Sdn Bhd 19 Mectalent Oy 14 Shenzhen Jcr Medical Technology Limited Company 11 Medesign I.C. Gmb H 8 Achim Ruthner Gmb H 7 President Dental Gmb H 3 Assure Tech. (Hangzhou) Co., Ltd. 2 Chungwoo Co., Ltd. 2 General Topics Srl 2 Genejet Biotech Co., Ltd. 2 Hangzhou Alltest Biotech.Co.,Ltd. 2 Hangzhou Frenovo Biotech Co.,Ltd. 2 Hangzhou Genesis Biodetection And Biocontrol Co., Ltd. 2 Hangzhou Immuno Biotech Co., Ltd 2 Hangzhou Realy Tech Co.,Ltd. 2 Joinstar Biomedical Technology Co., Ltd. 2 Rmedica Co.,Ltd 2 Sc Medicamed Market Srl 2 Shanghai Chemtron Biotech Co., Ltd. 2 Shenzhen Zijian Biotechnology Co., Ltd 2 + More Manufacturers

Competent Authority

Swedish Medical Products Agency 18 Ministry Of Health, Welfare And Sports 16 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 14 De/Ca304 Marktüberwachung Medizinprodukte Bayern 11 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 7 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 National Agency For Medicines And Medical Devices Of Romania 2 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 1 Federal Agency For Medicines And Health Products / / Health Products Division 1 Health Products Regulatory Authority, Medical Devices Department 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 štátny ústav Pre Kontrolu Liečiv / State Institute For Drug Control ( Slovak Ca) 1 + More Competent Authorities

Kind

Single Use 28 Implantable 15 Orthopedic 15 Active 5 Sterile 5 Kit 2 Medicinal Product 2 New Device 2 Professional Testing 2 Reagent 2 Reusable 2 + More Kinds

Classification

FDA Class 3 230 FDA Class 2 153 FDA Class 1 40 Eu Md Class 2b 29 Eu Md Class 1 28 Eu Md Class 2a 7 Eu Ivd Class A 3 FDA Unclassified 2 Eu Ivd Class B 1 + More Classifications

Notified Body

Eurofins Electric & Electronics Finland Oy 12 Tüv Rheinland Lga Products Gmb H 12 Mdc Medical Device Certification Gmbh 8 Ente Certificazione Macchine Srl 3 Istituto Superiore Di Sanita' 2 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 1 + More Notified Bodies

FDA FEI Number

3009882464 168 1000148471 166 1000306431 166 1121308 166 3003418325 166 3008087383 166 3004028763 116 3009617712 111 1000136573 94 2250051 93 3000308930 93 3002642396 93 3012963943 93 3002806944 90 2432235 88 3006198300 88 3011989923 88 3015550354 88 1036362 87 2517506 87 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 38 Eu Mdr 26 Eu Ivdr 4 + More Regulations

Authorized Representative

Medita Trading Ab 18 Vega Product Solutions Bv 18 Lotus Nl B.V. 12 Ajw Technology Consulting Gmb H 1 Cmc Medical Devices & Drugs Sl 1 Emergo Europe B.V. 1 Kingsmead Service B.V. 1 Medical Technology Promedt Consulting Gmb H 1 Shanghai International Holding Corp. Gmb H(europe) 1 + More Authorized Representatives

FDA Registration Number

3009882464 168 1121308 166 1221816 166 2029275 166 3003418325 166 3008087383 166 8044098 116 3009617712 111 1319681 94 2250051 93 3000308930 93 3002642396 93 3012963943 93 3002806944 90 2432235 88 3006198300 88 3011989923 88 3015550354 88 1036362 87 2517506 87 + More FDA Registration Numbers

FDA K Number

K010790 1 K042689 1 K050202 1 K052359 1 K060480 1 K062626 1 K091960 1 K202136 1 K202826 1 K203270 1 K223038 1 K242190 1 K760256 1 K760939 1 K761346 1 K771117 1 K780725 1 K781355 1 K781730 1 K781903 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 21 Mdd Annex Ii Section 4 12 Mdd Annex V 5 + More Certificate Types

Status

On The Market 34 + More Statuses

Lotus NL B.V.

Authorized representative

🇳🇱 Netherlands·584 Manufacturers·21427 Devices

<1 …132 133 134 135 136 >

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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