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BEUDAMED

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8,741 results · 36ms · Sources: EU EUDAMED, US FDA

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FDA UDI 6k FDA registration 2k FDA 510(k) 842 FDA Pre-Market Approval 370 Basic UDI-DI 33 Device 23 Manufacturer 6 FDA classification 5 Authorized representative 3 Importer 3 + More Filters

Country

United States 8k Ireland 163 Japan 154 China 101 Costa Rica 72 Canada 69 Netherlands 67 United Kingdom 57 Thailand 50 Switzerland 47 Mexico 45 Vietnam 37 Philippines 24 Brazil 22 Australia 20 Belgium 18 Czechia 16 Germany 14 Türkiye 13 Israel 8 + More Countries

Manufacturer

Atesos Medical Ag 16 Akzenta International Sa 15 Respironics Inc. 14 I Dna Laboratories ιδιωτικο διαγνωστικο εργαστηριο ανωνυμη εταιρεια 2 Braebon Medical Corporation 2 Guilin Woodpecker Medical Instrument Co., Ltd. 2 Px Dental Sa 2 Shenzhen Calibeur Industries Co., Ltd. 1 A&D Company, Limited 1 Amcaremed Technology Co., Limited 1 Amido (Beijing) Enterprises Limited 1 Anhui Jica Care Equipment Co.,Ltd 1 Anhui Remed Medical Products Co., Ltd. 1 Ankiya Bio Tec Co., Ltd. 1 Apostar Medical (Shanghai)limited. 1 Arsci Biomedical Inc. 1 Abomics Oy 1 Acare Medical Science Co., Ltd. 1 Accu Target Medi Pharma (Shanghai) Co., Ltd. 1 Ailex Technology Group Co., Ltd. 1 + More Manufacturers

Competent Authority

Austrian National Public Health Institute 16 De/Ca82, Landesdirektion Sachsen Referat Marktüberwachung 16 Ministry Of Health, Welfare And Sports 16 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 4 De/Ca304 Marktüberwachung Medizinprodukte Bayern 3 De/Ca22 Bezirksregierung Münster 2 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 2 National Organisation For Medicines 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 National Agency For Medicines And Medical Devices Of Romania 1 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 1 + More Competent Authorities

Kind

Implantable 16 Single Use 12 Active 10 Professional Testing 4 Kit 3 Measuring Function 2 Animal Tissues 1 Companion Diagnostics 1 Human Tissues 1 Reagent 1 Software 1 Sterilization 1 + More Kinds

Classification

FDA Class 2 842 FDA Class 3 370 Eu Md Class 2a 19 Eu Md Class 1 16 Eu Md Class 3 16 FDA Class 1 5 Eu Ivd Class C 2 Eu Ivd General 2 Eu Md Class 2b 1 + More Classifications

Notified Body

Schweizerische Vereinigung Für Qualitäts Und Managementsysteme 16 Tüv Süd Product Service Gmb H 14 Tüv Rheinland Lga Products Gmb H 2 Eurofins Electric & Electronics Finland Oy 1 + More Notified Bodies

FDA FEI Number

3002807314 947 2528981 864 2183744 853 2011171 828 3010155661 821 1000138054 815 1820334 812 1220477 802 1000112877 801 1000112968 801 3013557562 801 3016678045 801 1043214 800 3005011024 800 1000512168 799 1928237 799 3001236277 799 3008837339 799 3011050570 799 1000306431 798 + More FDA FEI Numbers

Regulation

Us FDA 9k Eu Mdd 33 Eu Mdr 19 Eu Ivdd 2 Eu Ivdr 2 + More Regulations

Authorized Representative

Hestomed Gmb H 16 Iqx Gmb H 15 Philips Medical Systems Nederland B.V. 14 Respironics Deutschland Gmb H & Co.Kg 14 C Epartner4 U 2 Med Net Ec Rep C I Ib Gmb H 2 Med Net Ec Rep Gmb H 2 Px France Sàrl 2 Caretechion Gmb H 1 Med Path Gmb H 1 Shanghai International Holding Corp. Gmb H(europe) 1 + More Authorized Representatives

FDA Registration Number

3002807314 947 2528981 864 2183744 853 2011171 828 3010155661 821 1319639 815 1820334 812 1220477 802 1043214 801 1054241 801 1055236 801 3013557562 801 3016678045 801 3005011024 800 1061124 799 1649518 799 1928237 799 3008837339 799 3011050570 799 1018233 798 + More FDA Registration Numbers

FDA K Number

K000011 1 K001033 1 K001198 1 K001251 1 K001454 1 K001736 1 K002206 1 K002212 1 K002289 1 K002346 1 K002707 1 K002907 1 K002962 1 K003084 1 K003394 1 K003398 1 K003483 1 K010497 1 K010511 1 K011084 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 31 Mdd Annex V 2 + More Certificate Types

Status

On The Market 22 No Longer On The Market 1 + More Statuses

MedPath GmbH

Authorized representative

🇩🇪 Germany·537 Manufacturers·13464 Devices

<1 …434 435 436 437 438 >

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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