GCX - BEUDAMED

BEUDAMED

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8,681 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 6k FDA registration 1k FDA Pre-Market Approval 396 Basic UDI-DI 309 FDA 510(k) 297 Device 287 Certificate 16 Authorized representative 7 Manufacturer 5 FDA classification 4 Importer 4 System producer 1 + More Filters

Country

United States 7k China 307 Japan 185 South Korea 95 Mexico 36 Germany 30 Netherlands 27 Canada 17 India 17 United Kingdom 16 Austria 13 France 10 Belgium 9 Finland 9 Ireland 9 Czechia 8 Taiwan 8 Switzerland 6 Vietnam 6 Hong Kong 5 + More Countries

Manufacturer

Nagor Limited 492 Gc Medis Corp. 65 Gc Medical Science Corporation 23 Lgc Clinical Diagnostics, Inc. 23 Acro Biotech Inc. 2 Bl Tech 2 Ben Q Materials Corporation 2 Cx Engineering Sp. Z O. O. 2 Conwell Medical Co., Ltd. 2 Dynamic Techno Medicals Pvt Ltd 2 Gencurix Inc. 2 Greiner Gmb H 2 Hangzhou Alltest Biotech.Co.,Ltd. 2 Igentify Ltd. 2 Js Medicina Electrónica Srl 2 Koru Pharma Co., Ltd 2 Lunit Inc. 2 Medi Thin Q. Co., Ltd. 2 Mi Co Bio Med Co., Ltd. 2 Nextbiomedical Co., Ltd. 2 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 495 Federal Agency For Medicines And Health Products / / Health Products Division 67 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 25 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 24 State Institute For Drug Control Medical Device Section 4 Agencia Española De Medicamentos Y Productos Sanitarios 3 Ministry Of Health, Welfare And Sports 3 De/Ca22 Bezirksregierung Münster 2 De/Ca37, Regierungspräsidium Stuttgart 2 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 2 De/Ca14 Senatorin Für Gesundheit, Frauen Und Verbraucherschutz 1 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 1 + More Competent Authorities

Kind

Single Use 257 Sterile 240 Implantable 173 Professional Testing 56 Near Patient Testing 42 Kit 33 Animal Tissues 27 Human Tissues 24 Reagent 23 Self Testing 21 Instrument 15 Active 2 Sterilization 2 + More Kinds

Classification

FDA Class 3 393 Eu Md Class 3 336 FDA Class 2 291 Eu Md Class 2a 132 Eu Ivd General 63 Eu Ivd Annex 2 List B 26 Eu Ivd Self Testing 16 FDA Class 1 13 Eu Md Class 2b 12 Eu Md Class 1 8 Eu Ivd Class A 3 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 493 Tüv Süd Product Service Gmb H 50 Dekra Certification B.V. 23 + More Notified Bodies

FDA FEI Number

2124215 396 3002807314 396 3010273872 396 2648729 393 3011120183 393 1000121056 392 2183744 392 3001451463 392 3002095335 392 3002806565 392 3004091615 392 1643817 389 2126666 389 3000203066 389 3000279201 389 3002631703 389 3002913962 389 3004742232 389 3004859241 389 3008814558 389 + More FDA FEI Numbers

Regulation

Us FDA 8k Eu Mdd 480 Eu Ivdd 105 Eu Mdr 8 Eu Ivdr 3 + More Regulations

Authorized Representative

Gc Aesthetics (Management) Limited 493 Obelis S.A. 65 Medi Mark Europe Sarl. 23 Medical Technology Promedt Consulting Gmb H 23 Cmc Medical Devices & Drugs Sl 1 Emergo Europe B.V. 1 Gce, S.R.O. 1 Med Net Ec Rep Gmb H 1 + More Authorized Representatives

FDA Registration Number

2124215 396 3002807314 396 3010273872 396 2648729 393 3011120183 393 1000121056 392 1225687 392 2134265 392 2183744 392 3004091615 392 9681260 392 1643817 389 2126666 389 2133810 389 3000279201 389 3002631703 389 3004742232 389 3004859241 389 3008814558 389 3014479313 389 + More FDA Registration Numbers

FDA K Number

K000055 1 K001769 1 K002156 1 K003247 1 K023407 1 K033058 1 K040976 1 K042454 1 K050652 1 K060935 1 K061193 1 K071277 1 K071280 1 K071283 1 K072115 1 K083809 1 K110530 1 K123586 1 K132638 1 K133728 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii Section 4 347 Mdd Annex Ii (Excluding Section 4) 147 Ivdd Annex Iv (Excluding Sections 4, 6) 73 + More Certificate Types

Status

On The Market 287 + More Statuses

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

<1 …431 432 433 434 435 >

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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