PGV - BEUDAMED

BEUDAMED

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5,421 results · 38ms · Sources: EU EUDAMED, US FDA

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FDA UDI 5k FDA Pre-Market Approval 283 FDA registration 168 FDA 510(k) 27 Basic UDI-DI 15 Device 8 FDA classification 5 Manufacturer 3 Authorized representative 2 Importer 2 System producer 1 + More Filters

Country

United States 5k China 20 Germany 13 Vietnam 13 Italy 9 Denmark 7 Netherlands 7 Slovakia 7 Spain 5 Türkiye 5 Costa Rica 3 Ireland 2 Israel 2 Mexico 2 Austria 1 Hong Kong 1 Pakistan 1 Thailand 1 Ukraine 1 + More Countries

Manufacturer

Vitrosens Biyoteknoloji Anonim şirketi 4 Xiamen Biotime Biotechnology Co., Ltd. 4 Pride Mobility Products Corporation 3 Shanghai Zymetas Medtech Co., Ltd 3 Auradonics, Inc. 2 Shanghai Zj Bio Tech Co., Ltd 2 Sejoy Biomedical Co., Ltd. 2 Shandong Haidike Medical Products Co Ltd 2 Afzal Saeed Manufacturing Corp 1 Aon Co.,Ltd 1 Aqualution Systems Ltd 1 Astar Orthodontics Inc. 1 Acme Monaco Corporation 1 Aditek Do Brasil Sa 1 Advanced Vision Science, Inc. 1 Aerotel Medical Systems (1998) Ltd. 1 Akervall Technologies, Inc 1 Ameda Instruments Company 1 Andent Dental Co.,Ltd 1 Blink Device Company 1 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 10 Turkish Medicine And Medical Devices Agency 5 Agencia Española De Medicamentos Y Productos Sanitarios 4 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 3 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 3 Austrian National Public Health Institute 2 Federal Agency For Medicines And Health Products / / Health Products Division 2 De/Ca304 Marktüberwachung Medizinprodukte Bayern 1 The Medicines And Healthcare Products Regulatory Agency 1 + More Competent Authorities

Kind

Kit 10 Professional Testing 10 Reagent 10 Single Use 7 Near Patient Testing 4 Companion Diagnostics 2 Animal Tissues 1 Implantable 1 Microbial Substances 1 Sterile 1 + More Kinds

Classification

FDA Class 3 282 FDA Class 2 31 Eu Ivd General 16 Eu Md Class 1 3 Eu Md Class 3 3 FDA Class 1 2 Eu Ivd Class C 1 + More Classifications

Notified Body

Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 3 + More Notified Bodies

FDA FEI Number

1721676 181 3003094851 179 2011171 178 3002807111 175 2020394 172 1721504 171 1721686 171 2017233 171 3002504068 171 3002806368 171 3006950086 171 3012536737 171 3015309643 171 3033589330 171 2124215 92 2183744 91 3005334138 90 3010273872 88 3002807314 87 1000121056 85 + More FDA FEI Numbers

Regulation

Us FDA 5k Eu Ivdd 16 Eu Mdd 3 Eu Mdr 3 Eu Ivdr 1 + More Regulations

Authorized Representative

Lotus Nl B.V. 7 Shanghai International Holding Corp. Gmb H(europe) 7 Medunion S.L. 5 Osen Gmb H 4 Sungo Cert Gmb H 4 Cmc Medical Devices & Drugs Sl 3 Pride Mobility Products Europe Bv 3 Sungo Europe B.V. 3 Obelis S.A. 2 Riomavix Ltd 2 Af Pharma Service Europe Sl 1 Ec Certification Service Gmb H 1 Luxus Lebenswelt Gmb H 1 Wellkang Ltd 1 + More Authorized Representatives

FDA Registration Number

1721676 181 1724474 179 2011171 178 3005941719 175 2020394 172 1721504 171 1721686 171 2017233 171 3002504068 171 3006950086 171 3012536737 171 3015309643 171 3033589330 171 9681442 171 2124215 92 2183744 91 3010273872 88 3002807314 87 1000121056 85 1225687 85 + More FDA Registration Numbers

FDA K Number

Den140002 1 K014124 1 K102473 1 K122367 1 K131002 1 K132195 1 K153069 1 K153605 1 K162478 1 K192385 1 K222212 1 K233881 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 3 + More Certificate Types

Status

On The Market 8 + More Statuses

Ortho Organizers GmbH

🇩🇪 Germany·34 Manufacturers

<1 …268 269 270 271 272 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

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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