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6,041 results · 41ms · Sources: EU EUDAMED, US FDA

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FDA UDI 5k FDA registration 428 FDA 510(k) 77 FDA Pre-Market Approval 45 Device 34 Basic UDI-DI 24 Importer 8 Authorized representative 3 FDA classification 3 Manufacturer 3 Certificate 1 + More Filters

Country

United States 6k China 247 Germany 64 Malaysia 21 Netherlands 14 Vietnam 12 Pakistan 9 France 8 Japan 8 South Korea 7 Switzerland 7 Türkiye 5 Costa Rica 2 India 2 Romania 2 United Kingdom 2 Belgium 1 Brazil 1 Canada 1 Finland 1 + More Countries

Manufacturer

Cell Projects Ltd 24 Counter Scientific Development (Gz) Limited 7 Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. 5 Klarity Medical & Equipment（Gz） Co.,Ltd. 5 Tosoh Corporation 5 Prodont Holliger 3 Suzhou Gzm Medical Co., Ltd 3 Angelus Indústria De Produtos Odontológicos S/A 2 Abrasive Technology Llc 2 Chien Ti Enterprise Co., Ltd. 2 Hangzhou Ags Med Tech Co.,Ltd. 2 Hefei C&P Nonwoven Products Co.,Ltd 2 Hollister Incorporated 2 Jessop Precision Products, Inc (Trading As The Suremark Company) 2 Jiangsu Bioperfectus Technologies Co., Ltd. 2 Jiangsu Vedkang Medical Science And Technology Co., Ltd. 2 Shangxian Minimal Invasive Inc. 2 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 2 Musculoskeletal Transplant Foundation 1 3 A Medical Products Co., Ltd 1 + More Manufacturers

Competent Authority

Malta Medicines Authority 25 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 7 De/Ca36 Regierungspräsidium Gießen Abteilung Ii Dezernat 25.1 Arbeitsschutz Gießen I 7 Ministry Of Health, Welfare And Sports 7 Federal Agency For Medicines And Health Products / / Health Products Division 6 Turkish Medicine And Medical Devices Agency 5 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 4 Health Products Regulatory Authority, Medical Devices Department 4 De/Ca22 Bezirksregierung Münster 2 National Agency For Medicines And Medical Devices Of Romania 2 Agencia Española De Medicamentos Y Productos Sanitarios 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 1 State Health Care Accreditation Agency Under The Ministry Of Health Of The Republic Of Lithuania 1 + More Competent Authorities

Kind

Single Use 29 Professional Testing 9 Reagent 7 Active 3 Kit 3 Sterilization 3 Instrument 2 Human Tissues 1 Near Patient Testing 1 + More Kinds

Classification

FDA Class 3 45 FDA Class 2 44 FDA Class 1 36 Eu Ivd Class A 28 Eu Md Class 2a 13 Eu Md Class 1 10 Eu Ivd General 5 Eu Ivd Class C 2 + More Classifications

Notified Body

Sgs Belgium Nv 7 Szutest Uygunluk Değerlendirme A.ş. 5 Dnv Product Assurance As 1 + More Notified Bodies

FDA FEI Number

3016763307 51 2011171 36 1417592 35 1928237 34 3010097171 31 3018094310 30 3009513193 29 3011215096 28 3013557562 26 3005581016 25 3012421607 25 3013298431 25 3030447506 25 1220477 24 3009429841 23 3013188547 23 3003418325 22 3001236277 21 3001236905 21 3010041430 21 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Ivdr 30 Eu Mdd 12 Eu Mdr 11 Eu Ivdd 5 + More Regulations

Authorized Representative

Advena Limited 24 Yyuka International Gb R 7 Tosoh Europe N.V. 5 Lotus Nl B.V. 3 Shanghai International Holding Corp. Gmb H(europe) 3 Emergo Europe B.V. 2 Hollister Ulc 2 Acorn Regulatory Consultancy Services Ltd 1 Caretechion Gmb H 1 Cepheid Europe S.A.S. 1 Med Net Ec Rep Gmb H 1 Obelis S.A. 1 + More Authorized Representatives

FDA Registration Number

3016763307 51 1417592 36 2011171 36 1928237 34 3010097171 31 3018094310 30 3009513193 29 3011215096 28 3013557562 26 3005581016 25 3012421607 25 3013298431 25 3030447506 25 1220477 24 3009429841 23 3013188547 23 3003418325 22 1423537 21 1649518 21 3010041430 21 + More FDA Registration Numbers

FDA K Number

K014200 1 K020853 1 K023882 1 K024169 1 K032282 1 K032344 1 K063461 1 K780250 1 K790713 1 K801432 1 K810485 1 K831071 1 K853161 1 K853179 1 K853180 1 K853181 1 K862971 1 K873933 1 K873934 1 K890216 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 13 + More Certificate Types

Status

On The Market 34 + More Statuses

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

<1 …299 300 301 302 303 >

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

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EU MDR

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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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