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BEUDAMED

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3,221 results · 38ms · Sources: EU EUDAMED, US FDA

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FDA registration 2k FDA UDI 743 FDA 510(k) 307 FDA Pre-Market Approval 238 Basic UDI-DI 104 Device 57 Manufacturer 4 Certificate 3 FDA classification 3 Authorized representative 2 Importer 2 + More Filters

Country

United States 2k Taiwan 572 South Korea 237 United Kingdom 200 Dominican Republic 175 Malaysia 120 China 103 Germany 92 Hong Kong 42 Canada 27 Mexico 22 Netherlands 18 France 13 Finland 12 Singapore 11 India 10 Indonesia 10 Israel 10 Pakistan 8 Sweden 4 + More Countries

Manufacturer

Micro Nx Co., Ltd. 55 Axg Industries Sdn Bhd 48 Beckman Coulter Inc. 46 Ng Biotech 6 Ng International & Co. K.S. 2 Ortoiberica S.L. 2 Snj Co., Ltd. 2 Jade Scientific Inc. Dba American Scientific Products, Chem Pure Chemicals 1 Minaris Medical Co., Ltd. 1 3 Nt Medical 1 A Mi Global Co., Ltd. 1 A Spine Asia Co., Ltd. 1 Aceonedent Korea Industrial Co. 1 Agd Biomedicals Pvt. Ltd 1 Aider Inc. 1 Alphagene Co., Ltd. 1 Ami Inc. 1 Amolifescience Co., Ltd. 1 Aneuvo 1 Anjir Talaee 1 + More Manufacturers

Competent Authority

De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 56 Federal Agency For Medicines And Health Products / / Health Products Division 49 Health Products Regulatory Authority, Medical Devices Department 46 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 7 štátny ústav Pre Kontrolu Liečiv / State Institute For Drug Control ( Slovak Ca) 3 Agencia Española De Medicamentos Y Productos Sanitarios 2 De/Ca38 Regierungspräsidium Karlsruhe 2 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 2 Ministry Of Health, Welfare And Sports 2 Malta Medicines Authority 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 National Agency For Medicines And Medical Devices Of Romania 1 + More Competent Authorities

Kind

Professional Testing 49 Reagent 48 Microbial Substances 32 Single Use 28 Active 26 Sterilization 26 Latex 23 Animal Tissues 19 Kit 4 Human Tissues 2 Administering Medicine 1 Medicinal Product 1 Near Patient Testing 1 New Device 1 Sterile 1 + More Kinds

Classification

FDA Class 2 263 FDA Class 3 235 Eu Md Class 2a 55 Eu Md Class 1 52 Eu Ivd General 48 FDA Class 1 48 Eu Ivd Class A 3 Eu Ivd Class B 3 FDA Unclassified 2 + More Classifications

Notified Body

Sgs Belgium Nv 37 Szutest Uygunluk Değerlendirme A.ş. 18 Istituto Superiore Di Sanita' 1 Tüv Süd Product Service Gmb H 1 + More Notified Bodies

FDA FEI Number

3013500228 377 3013596024 377 3000203466 340 1720929 232 3026408938 231 3006950086 228 3012536737 228 3015309643 228 3033589330 228 2648045 226 3015173212 223 3005846326 220 3009617712 218 3005770916 215 3000126629 197 2015691 193 3002807167 192 3002806783 191 3004415095 181 3007836437 181 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 54 Eu Mdr 53 Eu Ivdd 48 Eu Ivdr 6 + More Regulations

Authorized Representative

Javi Tech E.K. 55 Obelis S.A. 48 Beckman Coulter Ireland Inc. 46 Advena Limited 1 Bausch & Lomb Gmb H 1 Philips Medical Systems Nederland B.V. 1 Respironics Deutschland Gmb H & Co.Kg 1 Sungo Europe B.V. 1 + More Authorized Representatives

FDA Registration Number

3013500228 377 3013596024 377 2133641 340 1720929 232 3026408938 231 3006950086 228 3012536737 228 3015309643 228 3033589330 228 2648045 226 3015173212 223 3004519921 221 3009617712 218 3005770916 216 3000126629 197 2015691 193 9610105 190 3008729547 187 3004415095 181 3007836437 181 + More FDA Registration Numbers

FDA K Number

K000664 1 K001762 1 K010049 1 K021874 1 K023960 1 K032997 1 K040287 1 K042144 1 K043103 1 K060660 1 K060898 1 K062134 1 K071631 1 K072735 1 K073113 1 K080116 1 K081776 1 K082308 1 K091786 1 K092219 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 38 Mdd Annex V 19 + More Certificate Types

Status

On The Market 57 + More Statuses

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

<1 …158 159 160 161 162 >

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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