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BEUDAMED

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3,081 results · 40ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA Pre-Market Approval 547 FDA registration 542 FDA 510(k) 148 Device 137 Importer 120 Certificate 42 Basic UDI-DI 15 FDA classification 8 Authorized representative 7 Manufacturer 7 System producer 5 + More Filters

Country

United States 2k France 165 China 95 Portugal 67 Germany 53 United Kingdom 39 Switzerland 29 Poland 27 Italy 22 Netherlands 21 Singapore 21 Australia 20 Costa Rica 15 Sweden 14 Spain 10 Finland 9 Ireland 9 Malaysia 9 Belgium 8 Canada 8 + More Countries

Manufacturer

Instrumentation Laboratory Company 69 Mts Maschinenbau Ag 25 Bioptimal International Pte. Ltd. 12 Harps Investment Asia Pte. Ltd. 11 Ellex Medical Pty Ltd 10 Mts Medical Ag (Aktiengesellschaft) 10 Camp Scandinavia Ab 9 Shenzhen Comen Medical Instruments Co.,Ltd. 7 Xavant Technology (Pty) Ltd 7 Care Essentials Pty Ltd 6 Osteopore International Pte Ltd 6 Teco Medical Instruments, Production + Trading Gmb H 6 Advanced Ophthalmic Innovations Pte. Ltd. 5 Haag Streit Ag 5 Haag Streit Uk Ltd 5 Insight Medical Products Ltd 5 Ivor Shaw Ltd Trading As Pennine Healthcare 5 Qlicksmart Pty Ltd 5 Shenzhen Huge Med Medical Technical Development Co., Ltd. 5 Sun Tech Medical, Inc 5 + More Manufacturers

Competent Authority

Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 82 State Institute For Drug Control Medical Device Section 35 Ministry Of Health, Welfare And Sports 32 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 15 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 14 De/Ca304 Marktüberwachung Medizinprodukte Bayern 11 Swedish Medical Products Agency 11 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 10 De/Ca39, Regierungspräsidium Freiburg Referat 25 10 Federal Agency For Medicines And Health Products / / Health Products Division 10 Agencia Española De Medicamentos Y Productos Sanitarios 9 Health Products Regulatory Authority, Medical Devices Department 9 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 8 Malta Medicines Authority 8 De/Ca30 Regierungspräsidium Kassel Dezernat 55 Medizinprodukte Und Produktsicherheitsrecht 6 National Agency For Medicines And Medical Devices Of Romania 5 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 4 De/Ca21 Bezirksregierung Köln Dezernat 24 4 De/Ca22 Bezirksregierung Münster 4 Danish Medicines Agency, Pharmacovigilance & Medical Devices 4 + More Competent Authorities

Kind

Single Use 10 Active 8 Sterile 5 Professional Testing 4 Reagent 3 Animal Tissues 1 Instrument 1 Orthopedic 1 + More Kinds

Classification

FDA Class 3 540 FDA Class 2 95 Eu Ivd Class A 72 FDA Class 1 61 Eu Md Class 1 55 Eu Md Class 2b 10 Eu Md Class 2a 7 Eu Ivd General 6 FDA Unclassified 4 Eu Md Class 3 2 + More Classifications

Notified Body

Dekra Certification B.V. 8 Tüv Rheinland Lga Products Gmb H 7 Tüv Süd Product Service Gmb H 7 Bsi Group The Netherlands B.V. 6 Dqs Medizinprodukte Gmb H 5 Bqs. S.R.O. 3 Istituto Superiore Di Sanita' 2 Dnv Product Assurance As 1 Eurofins Electric & Electronics Finland Oy 1 Sgs Belgium Nv 1 Szutest Uygunluk Değerlendirme A.ş. 1 Therapeutic Goods Administration 1 + More Notified Bodies

FDA FEI Number

2124215 205 3009380063 163 2011171 148 3009189893 127 3018094310 126 2183744 118 3002904345 117 1000125183 116 3003120897 116 3002807314 114 1028232 110 3006705815 104 3002806500 103 3000203466 102 2649622 101 3003574398 99 2648729 94 3000206435 94 3002618605 94 3010273872 92 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdr 73 Eu Ivdr 72 Eu Ivdd 6 Eu Mdd 1 + More Regulations

Authorized Representative

Instrumentation Laboratory Sp A 69 Mts Systemtechnik S.R.O. 27 Shanghai International Holding Corp. Gmb H(europe) 9 Emergo Europe B.V. 8 Advena Limited 6 Cmc Medical Devices & Drugs Sl 4 Mp Biomedicals Germany Gmb H 4 Med Envoy Global Bv 4 Vela Diagnostics Germany Gmb H 4 Mdss Gmb H 3 Pride Mobility Products Europe Bv 3 Compliance Management Solutions Europe Ltd 2 Med Path Gmb H 2 Med R Ar Services B.V. 2 Medical Technology Promedt Consulting Gmb H 2 Obelis S.A. 2 Burnshield Europe B.V. 1 Donawa Lifescience Consulting Srl 1 E C Rep Limited 1 European Healthcare & Device Solutions Ltd. 1 + More Authorized Representatives

FDA Registration Number

2124215 205 3009380063 163 2011171 148 3009189893 127 3018094310 126 2183744 118 9611579 117 2028492 116 3003120897 116 3002807314 114 1028232 110 3006705815 104 9610139 103 2133641 102 2649622 101 2032521 99 2030624 94 2648729 94 9616693 94 3010273872 92 + More FDA Registration Numbers

FDA K Number

Den200033 1 K014124 1 K053021 1 K102473 1 K122367 1 K131002 1 K153069 1 K771219 1 K791846 1 K801400 1 K801641 1 K833297 1 K834565 1 K891906 1 K900339 1 K902116 1 K905008 1 K951091 1 K953963 1 K963756 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 17 Ivdd Annex Iv (Excluding Sections 4, 6) 6 Ivdd Annex Iv Section 4 6 Mdd Annex Ii Section 4 6 Mdd Annex V 4 Aimdd Annex Ii Section 4 2 Mdd Annex Vi 1 Mdr Qms 1 + More Certificate Types

Status

On The Market 137 + More Statuses

MedPath GmbH

Authorized representative

🇩🇪 Germany·537 Manufacturers·13464 Devices

<1 …151 152 153 154 155 >

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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