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BEUDAMED

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5,641 results · 42ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k Device 1k Basic UDI-DI 824 FDA Pre-Market Approval 563 FDA registration 365 FDA 510(k) 60 Manufacturer 34 FDA classification 15 Importer 13 Certificate 10 Authorized representative 5 System producer 1 + More Filters

Country

United States 3k Türkiye 2k El Salvador 58 Switzerland 36 China 35 Italy 31 France 21 Germany 20 Iran 13 Jordan 13 Poland 13 Hong Kong 11 Netherlands 11 Bulgaria 10 Finland 10 India 9 Romania 8 Canada 6 Ireland 6 Pakistan 6 + More Countries

Manufacturer

Aero Medi̇kal Sağlik Turi̇zmi̇ Tibbi̇ ürünler Ve İth. İhr. San. Ti̇c. Ltd. şti̇. 869 Ags Medi̇kal ürünleri̇ İth. İhr. Ti̇c. A.ş. 586 Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.ş. 156 Zirc Dental Products Inc. 105 Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.Ltd. şti̇ 68 Polydentia Sa 22 İnnomed Laboratuvar İth. İhr. San. Tic. Ltd. şti. 12 Opharm S.A. 11 New Style 10 Zerkaya Teksti̇l Medi̇kal Gida İnşaat İth. İhr. San. Ve Ti̇c. Ltd. şti̇. 10 Dort A Tip Malz San Ith Ihr Tic Ltd Sti 6 Ann Reeves & Francesca S.A. 5 Care Care Oy 5 Di̇sposed Sağlik ürünleri̇ üreti̇m San.Ve Ti̇c. İth. İhr. Ltd 5 Temra International Ltd 4 Biolot Medikal Malzemeleri Arge İth. İhr. Aş. 2 Everyway Medical Instrument Co., Ltd. 2 Gold Standard Diagnostics Kassel Gmb H 2 Hedef İşi̇tme Ci̇h. Ve Tibbi̇ Ci̇h. İth. İhr. San. Ti̇c. Ltd.şti̇. 2 My Ti̇caret Ve Medi̇kal Anoni̇m şi̇rketi̇ 2 + More Manufacturers

Competent Authority

Turkish Medicine And Medical Devices Agency 2k De/Ca21 Bezirksregierung Köln Dezernat 24 105 Office Of Public Health 23 Ministry Of Health, Welfare And Sports 13 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 12 Bulgarian Drug Agency Department "Market Supervision And Lnspections" Division "Medical Devices" 10 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 10 National Agency For Medicines And Medical Devices Of Romania 8 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 7 Agencia Española De Medicamentos Y Productos Sanitarios 5 Malta Medicines Authority 5 Health Products Regulatory Authority, Medical Devices Department 4 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 4 Federal Agency For Medicines And Health Products / / Health Products Division 3 Infarmed – National Authority Of Medicines And Health Products, I.P 3 Austrian National Public Health Institute 2 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 2 De/Ca30 Regierungspräsidium Kassel Dezernat 55 Medizinprodukte Und Produktsicherheitsrecht 2 Ministère De La Santé Direction De La Santé Division De La Pharmacie Et Des Médicament Médical Devices Unit 2 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 + More Competent Authorities

Kind

Single Use 816 Sterilization 569 Implantable 529 Sterile 202 Reprocessed 7 Orthopedic 4 Reusable 3 Active 2 Animal Tissues 2 Professional Testing 2 Reagent 2 Administering Medicine 1 + More Kinds

Classification

Eu Md Class 2b 1k FDA Class 3 562 Eu Md Class 1 492 FDA Class 2 39 FDA Class 1 25 Eu Md Class 2a 13 FDA Not Classified 9 Eu Ivd General 2 + More Classifications

Notified Body

Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 870 Kiwa Belgelendirme Hizmetleri A.ş. 560 Ht Cert (Health Technology Certification Ltd) 6 Tüv Rheinland Lga Products Gmb H 2 Udem Adriatic D.O.O. 2 Bsi Group The Netherlands B.V. 1 + More Notified Bodies

FDA FEI Number

3005334138 557 3002806603 556 3000206435 553 2011171 552 3010432890 549 2015691 548 2025587 548 2183744 548 3001883144 548 3002534070 548 3007063218 548 3007113487 548 3010421104 548 3014918977 548 1713910 547 3002808437 547 3004478276 547 3005687633 547 3012179728 547 3005748481 35 + More FDA FEI Numbers

Regulation

Us FDA 4k Eu Mdd 1k Eu Mdr 496 Eu Ivdd 2 + More Regulations

Authorized Representative

Medicom Gmb H 105 Idd International Dental Distributors Ag 23 Sungo Europe B.V. 6 Advena Limited 1 Bykaralar Makina Medikal Gida Ins. Taah. Ith. Ihr. San. Tic. Ltd. Sti. 1 Cmc Medical Devices & Drugs Sl 1 Emergo Europe B.V. 1 Eurolink Europe Compliance Limited 1 Labomed Europe B.V. 1 Ukalia Limited 1 Vitaimed Gmb H 1 Mdi Europa Gmb H 1 + More Authorized Representatives

FDA Registration Number

3002806603 556 2030624 553 2011171 552 3010432890 549 2015691 548 2025587 548 2135147 548 2183744 548 3001883144 548 3007063218 548 3007113487 548 3010421104 548 3014918977 548 9617601 548 3004478276 547 3005687633 547 3008500478 547 3012179728 547 9612515 547 3005748481 35 + More FDA Registration Numbers

FDA K Number

Den070009 1 K070675 1 K080252 1 K081092 1 K101454 1 K121046 1 K130010 1 K141142 1 K141771 1 K180607 1 K201902 1 K210973 1 K811688 1 K863936 1 K870847 1 K870848 1 K872656 1 K875054 1 K915776 1 K934549 1 + More FDA K Numbers

Certificate Type

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

Status

On The Market 1k No Longer On The Market 2 + More Statuses

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices

<1 …279 280 281 282 283 >

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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