Bedal - BEUDAMED

BEUDAMED

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3,841 results · 52ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 280 Device 177 FDA 510(k) 88 Basic UDI-DI 46 FDA Pre-Market Approval 16 Manufacturer 3 FDA classification 1 + More Filters

Country

United States 3k China 118 Belgium 58 Germany 43 Türkiye 23 Canada 21 Taiwan 21 India 20 France 16 Spain 9 Pakistan 8 Switzerland 8 United Kingdom 8 Poland 7 Mexico 6 Netherlands 6 Italy 5 Malaysia 5 Vietnam 5 South Korea 4 + More Countries

Manufacturer

Bedal International 46 Walter Haverich Gmb H 23 Hemodia Sas 11 Stockert Gmb H 8 Daddy D Pro 7 Laboratorios Conda S.A. 7 Mvs In Motion 5 Ast Vision Care Inc. 4 Meril Life Sciences Pvt. Ltd. 4 Oertli Instrumente Ag 4 Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 3 Richter Rubber Technology Sdn Bhd 3 Tianjin Zhengtian Medical Instrument Co., Ltd. 3 3 R Indústria E Comércio Ltda 2 Aero Medi̇kal Sağlik Turi̇zmi̇ Tibbi̇ ürünler Ve İth. İhr. San. Ti̇c. Ltd. şti̇. 2 Atlas Cerrahi̇ Aletler Ltd. şti̇. 2 Asel Tibbi Aletler A.S. 2 Batrik Medical Manufacturing Inc. 2 Besmed Health Business Corp. 2 Bien Air Surgery Sa 2 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 61 De/Ca19 Bezirksregierung Detmold Dezernat 24 23 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 20 Ministry Of Health, Welfare And Sports 20 Turkish Medicine And Medical Devices Agency 20 Agencia Española De Medicamentos Y Productos Sanitarios 13 De/Ca39, Regierungspräsidium Freiburg Referat 25 12 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 9 De/Ca38 Regierungspräsidium Karlsruhe 9 Malta Medicines Authority 6 Austrian National Public Health Institute 4 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 4 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 4 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 4 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 Health Products Regulatory Authority, Medical Devices Department 2 Infarmed – National Authority Of Medicines And Health Products, I.P 2 State Institute For Drug Control Medical Device Section 2 Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia: Medical Devices Division / Pharmaceutical Inspection Division – Medical Devices Unit 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 + More Competent Authorities

Kind

Single Use 87 Sterile 44 Sterilization 29 Implantable 12 Active 6 Reusable 5 Latex 3 Administering Medicine 2 Measuring Function 2 Orthopedic 2 Medicinal Product 1 Professional Testing 1 Reagent 1 + More Kinds

Classification

Eu Md Class 1 147 FDA Class 2 88 Eu Md Class 2b 31 Eu Md Class 2a 23 FDA Class 3 16 Eu Md Class 3 12 Eu Ivd Class A 8 Eu Ivd General 2 FDA Class 1 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 8 Kiwa Belgelendirme Hizmetleri A.ş. 7 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 6 Sgs Belgium Nv 5 Dekra Certification B.V. 4 Mtic Inter Cert S.R.L. 3 Polskie Centrum Badan I Certyfikacji S.A. 3 Dqs Medizinprodukte Gmb H 2 Ht Cert (Health Technology Certification Ltd) 2 Tuv Nord Polska Sp. Z O.O 2 Tüv Rheinland Lga Products Gmb H 2 Tüv Süd Product Service Gmb H 2 Dnv Product Assurance As 1 Kiwa Cermet Italia S.P.A. 1 Szutest Uygunluk Değerlendirme A.ş. 1 + More Notified Bodies

FDA FEI Number

1928237 87 1043214 80 1000114111 78 1417592 78 3006791146 78 3000957797 77 1000109969 75 2182318 75 2648727 75 3003600763 75 3007836437 75 3005012805 74 3014421917 74 1824206 73 1831750 73 3007289408 73 1000118429 72 1000122786 72 1000143830 72 1000211739 72 + More FDA FEI Numbers

Regulation

Us FDA 4k Eu Mdr 158 Eu Mdd 55 Eu Ivdr 8 Eu Ivdd 2 + More Regulations

Authorized Representative

Antex Medi Solution 8 Advena Limited 6 Obelis S.A. 6 Sungo Europe B.V. 5 Cmc Medical Devices & Drugs Sl 4 Mdss Gmb H 4 Oertli Ophthalmedic österreich Gmb H 4 Mdi Europa Gmb H 4 Bricon Gmb H 3 Emergo Europe B.V. 3 Inion Oy 3 Umedwings Netherlands B.V. 3 Rrt Vertrieb Und Service Gmb H 3 Bien Air Europe Sàrl 2 Cables And Sensors B.V. 2 Casus Europe B.V. 2 Cinterqual Soluções De Comércio Internacional,Lda. 2 G. Van Wageningen B.V. 2 Medten Eu Ap S 2 Shanghai International Holding Corp. Gmb H(europe) 2 + More Authorized Representatives

FDA Registration Number

1928237 87 1043214 80 1054713 78 1417592 78 3006791146 78 1066270 77 2182318 75 3003600763 75 3005012805 75 3007836437 75 2648727 74 3014421917 74 1824206 73 1831750 73 3007289408 73 9616345 73 1000122786 72 1000211739 72 1000252066 72 1224873 72 + More FDA Registration Numbers

FDA K Number

K103536 1 K202964 1 K780371 1 K790049 1 K811897 1 K821185 1 K830559 1 K831821 1 K843781 1 K851551 1 K852674 1 K853270 1 K854832 1 K854867 1 K854937 1 K864172 1 K864186 1 K872923 1 K872924 1 K872925 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 38 Mdd Annex Ii Section 4 12 Mdd Annex V 7 + More Certificate Types

Status

On The Market 177 + More Statuses

xReader System

ESCREEN, INC.·00867802000290·The xReader System consists of a small, portabl...

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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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