GCW - BEUDAMED

BEUDAMED

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6,281 results · 41ms · Sources: EU EUDAMED, US FDA

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FDA UDI 5k FDA registration 541 Basic UDI-DI 331 Device 314 FDA Pre-Market Approval 156 FDA 510(k) 151 Certificate 18 Importer 10 Authorized representative 7 Manufacturer 5 FDA classification 4 System producer 1 + More Filters

Country

United States 5k South Korea 92 China 86 Pakistan 66 Germany 61 Taiwan 27 India 19 Netherlands 19 Canada 16 United Kingdom 13 Czechia 11 Mexico 10 Hong Kong 8 Japan 8 Malaysia 5 Spain 5 Switzerland 5 Australia 4 Belgium 4 France 4 + More Countries

Manufacturer

Nagor Limited 492 Gc Medis Corp. 65 Scw Medicath Ltd. 41 Lgc Clinical Diagnostics, Inc. 38 Gc Medical Science Corporation 23 Besmed Health Business Corp. 10 Neotech Products Llc 3 Bl Tech 2 Ben Q Materials Corporation 2 Dynamic Techno Medicals Pvt Ltd 2 Gencurix Inc. 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 Mirion Technologies (Capintec), Inc. 2 Nextbiomedical Co., Ltd. 2 Optolane Technologies Inc. 2 Sequoia Twn Healthcare Co., Ltd. 2 + More Manufacturers

Competent Authority

Health Products Regulatory Authority, Medical Devices Department 497 Federal Agency For Medicines And Health Products / / Health Products Division 102 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 40 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 24 Ministry Of Health, Welfare And Sports 11 State Institute For Drug Control Medical Device Section 6 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca14 Senatorin Für Gesundheit, Frauen Und Verbraucherschutz 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 De/Ca304 Marktüberwachung Medizinprodukte Bayern 1 Malta Medicines Authority 1 + More Competent Authorities

Kind

Single Use 289 Sterile 255 Implantable 173 Professional Testing 55 Near Patient Testing 42 Kit 33 Animal Tissues 27 Human Tissues 24 Reagent 22 Self Testing 21 Instrument 15 + More Kinds

Classification

Eu Md Class 3 336 Eu Md Class 2a 156 FDA Class 3 130 FDA Class 2 105 Eu Ivd General 78 FDA Class 1 75 Eu Ivd Annex 2 List B 26 Eu Md Class 1 19 Eu Ivd Self Testing 16 Eu Md Class 2b 12 Eu Ivd Class A 2 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 493 Tüv Süd Product Service Gmb H 50 Dekra Certification B.V. 48 Tüv Rheinland Lga Products Gmb H 25 + More Notified Bodies

FDA FEI Number

2124215 124 3005099803 124 3013960851 124 3013987875 124 2020550 107 3007475226 107 3011050570 105 3003418325 103 3014342096 103 3002808268 102 1221826 101 3006546082 101 1421101 100 3002807072 100 3002808001 100 3004001706 100 3007137643 100 3012322232 100 3000204191 99 3002807798 99 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Mdd 512 Eu Ivdd 120 Eu Mdr 11 Eu Ivdr 2 + More Regulations

Authorized Representative

Gc Aesthetics (Management) Limited 493 Obelis S.A. 98 Medi Mark Europe Sarl. 38 Eunitor Gmb H 33 Medical Technology Promedt Consulting Gmb H 23 Casus Europe B.V. 10 Mdi Europa Gmb H 10 Atlantico Systems, Ltd. 2 Cmc Medical Devices & Drugs Sl 1 Gce, S.R.O. 1 + More Authorized Representatives

FDA Registration Number

2124215 124 3005099803 124 3013960851 124 3013987875 124 2020550 107 3010202439 107 3011050570 105 3003418325 103 3014342096 103 3012322232 102 9610617 102 1221826 101 3006546082 101 3010707607 101 1421101 100 3004001706 100 3007137643 100 2085947 99 3012507533 98 9611102 98 + More FDA Registration Numbers

FDA K Number

K000229 1 K012265 1 K032430 1 K041852 1 K062230 1 K062231 1 K062523 1 K063477 1 K081477 1 K082813 1 K091968 1 K093792 1 K121378 1 K121724 1 K123359 1 K123956 1 K131226 1 K140951 1 K163412 1 K191602 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii Section 4 347 Mdd Annex Ii (Excluding Section 4) 182 Ivdd Annex Iv (Excluding Sections 4, 6) 88 + More Certificate Types

Status

On The Market 314 + More Statuses

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

<1 …311 312 313 314 315 >

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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