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3,581 results · 44ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA registration 952 Basic UDI-DI 266 FDA 510(k) 228 Device 190 FDA Pre-Market Approval 19 Manufacturer 9 FDA classification 8 Importer 4 Authorized representative 3 + More Filters

Country

United States 2k Germany 592 Malaysia 229 China 166 India 63 Italy 48 France 32 United Kingdom 31 Türkiye 13 Pakistan 12 South Korea 11 Hungary 8 Madagascar 7 Belgium 6 Canada 6 Japan 5 Poland 5 Spain 4 Egypt 3 Israel 3 + More Countries

Manufacturer

Phantom Laboratory 204 Shenzhen Zuowei Technology Co.,Ltd. 135 Off Carr Srl 13 Bio Plus Co., Ltd. 6 Ff Fémfeldolgozó Zrt. 4 Ast Vision Care Inc. 3 Becker Orthopedic Appliance Company 3 Ch M Spółka Z Ograniczoną Odpowiedzialnością 3 Sanatmetal Orthopaedic And Traumatologic Equipment Manufacturer Ltd. 3 Atlas Cerrahi̇ Aletler Ltd. şti̇. 2 Aysam Ortopedi Ve Tıbbi Aletler Sanayi Ve Ticaret Limited şirketi 2 Bonegraft Biomaterials Co. 2 Daddy D Pro 2 Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. 2 Eff Dental Componentes Ltda 2 Greiner Bio One Gmb H 2 Kirwan Surgical Products Llc 2 Meril Life Sciences Pvt. Ltd. 2 Miracle Medical Industries 2 Pride Mobility Products Corporation 2 + More Manufacturers

Competent Authority

Swedish Medical Products Agency 208 Ministry Of Health, Welfare And Sports 151 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 18 Turkish Medicine And Medical Devices Agency 13 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 9 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 8 Federal Agency For Medicines And Health Products / / Health Products Division 6 Health Products Regulatory Authority, Medical Devices Department 6 Agencia Española De Medicamentos Y Productos Sanitarios 5 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 5 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 5 De/Ca304 Marktüberwachung Medizinprodukte Bayern 4 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 3 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 2 De/Ca10 Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte 2 De/Ca36 Regierungspräsidium Gießen Abteilung Ii Dezernat 25.1 Arbeitsschutz Gießen I 2 De/Ca37, Regierungspräsidium Stuttgart 2 De/Ca38 Regierungspräsidium Karlsruhe 2 De/Ca39, Regierungspräsidium Freiburg Referat 25 2 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 2 + More Competent Authorities

Kind

Active 157 Reusable 119 Single Use 39 Sterilization 25 Sterile 20 Human Tissues 13 Implantable 8 Animal Tissues 5 Administering Medicine 2 Reagent 2 Kit 1 Near Patient Testing 1 Professional Testing 1 Self Testing 1 + More Kinds

Classification

Eu Md Class 1 390 FDA Class 1 149 FDA Class 2 84 Eu Md Class 2a 25 Eu Md Class 2b 14 Eu Md Class 3 13 FDA Class 3 12 Eu Ivd General 6 Eu Ivd Class A 5 Eu Ivd Self Testing 2 Eu Ivd Class B 1 FDA Not Classified 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 7 Bsi Group The Netherlands B.V. 5 Tüv Rheinland Lga Products Gmb H 4 Sgs Belgium Nv 3 Tüv Süd Product Service Gmb H 3 Dekra Certification Gmb H 2 Dqs Medizinprodukte Gmb H 2 Ht Cert (Health Technology Certification Ltd) 2 Kiwa Cermet Italia S.P.A. 2 Kiwa Belgelendirme Hizmetleri A.ş. 2 Turkish Standards Institution (Tse) 2 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 2 Elektrotechnický Zkušební ústav, S.P. 1 Imq Istituto Italiano Del Marchio Di Qualità S.P.A. 1 Intertek Semko Ab 1 Mtic Inter Cert S.R.L. 1 Tuv Nord Polska Sp. Z O.O 1 + More Notified Bodies

FDA FEI Number

3010707607 263 3014164734 153 3006552561 151 3010602489 151 1417592 145 3002808366 144 3013557562 142 3001236905 141 3003699698 139 2648727 135 3012421607 135 3014421917 134 3011209798 132 3012104670 132 3015997711 132 2939388 131 3002808507 131 3003199637 131 3010220595 131 1000153304 130 + More FDA FEI Numbers

Regulation

Us FDA 3k Eu Mdd 239 Eu Mdr 203 Eu Ivdd 8 Eu Ivdr 6 + More Regulations

Authorized Representative

Hoff & Lowendahl Ab 207 Sungo Europe B.V. 137 Ktr Europe Gmb H 8 Shanghai International Holding Corp. Gmb H(europe) 5 Emergo Europe B.V. 4 Mdss Gmb H 4 Obelis S.A. 4 Acorn Regulatory Consultancy Services Ltd 3 Lotus Nl B.V. 3 Med Path Gmb H 3 Mps Medical Product Service Gmb H 2 Antex Medi Solution 2 Advena Limited 2 Cmc Medical Devices & Drugs Sl 2 Med Envoy Global Bv 2 Pride Mobility Products Europe Bv 2 Riomavix Ltd 2 Share Info Consultant Service Llc 2 Umedwings Netherlands B.V. 2 Young Microbrush Ireland Ltd 2 + More Authorized Representatives

FDA Registration Number

3010707607 263 3014164734 153 3006552561 151 3010602489 151 1417592 145 3013557562 142 1423537 141 3003699698 139 2648727 135 3012421607 135 3014421917 134 3011209798 132 3012104670 132 3015997711 132 2939388 131 3003199637 131 3010220595 131 8041005 131 3006367442 130 3006796582 130 + More FDA Registration Numbers

FDA K Number

Den200016 1 K002799 1 K020566 1 K023239 1 K023240 1 K024162 1 K031393 1 K033038 1 K033187 1 K033277 1 K041237 1 K052000 1 K052889 1 K061069 1 K082085 1 K082388 1 K100375 1 K103757 1 K111369 1 K120169 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 22 Mdd Annex Ii Section 4 17 Mdd Annex V 4 Ivdd Annex Iv (Excluding Sections 4, 6) 2 + More Certificate Types

Status

On The Market 189 Not Intended For Eu Market 1 + More Statuses

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

<1 …176 177 178 179 180 >

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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