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1,621 results · 43ms · Sources: EU EUDAMED, US FDA

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FDA UDI 948 FDA registration 345 FDA 510(k) 148 Basic UDI-DI 107 FDA Pre-Market Approval 44 Device 17 FDA classification 4 Importer 4 Authorized representative 2 Manufacturer 2 + More Filters

Country

United States 1k China 139 Canada 39 Türkiye 19 Hong Kong 18 Brazil 17 Germany 17 Malaysia 11 Switzerland 9 India 8 Netherlands 8 Japan 7 United Kingdom 7 Israel 6 Isle Of Man 5 South Korea 5 Taiwan 5 Italy 4 Czechia 3 France 3 + More Countries

Manufacturer

Maccura Biotechnology Co., Ltd. 17 Lhm Medical Technology (Hong Kong) Limited 15 Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. 14 Hangzhou Alltest Biotech.Co.,Ltd. 7 Xiamen Biotime Biotechnology Co., Ltd. 7 Shenzhen Superbio Technology Co.,Ltd. 4 Accu Bio Tech Co., Ltd. 3 Atlas Link Technology Co., Ltd. 3 Genrui Biotech Inc. 3 Vitrosens Biyoteknoloji Anonim şirketi 3 Wuhan Life Origin Biotech Joint Stock Co., Ltd. 3 Getein Biotech, Inc. 2 Linear Chemicals S.L.U 2 Pride Mobility Products Corporation 2 Sejoy Biomedical Co., Ltd. 2 Shenzhen Zijian Biotechnology Co., Ltd 2 Suzhou Hokapi Biomedical Engineering Co., Ltd.. 2 Tianjin Mingao Biotechnology Co.，Ltd 2 Trate Ag 2 Tianjin New Bay Bioresearch Co., Ltd. 2 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 40 Turkish Medicine And Medical Devices Agency 18 De/Ca304 Marktüberwachung Medizinprodukte Bayern 16 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 13 De/Ca22 Bezirksregierung Münster 8 Agencia Española De Medicamentos Y Productos Sanitarios 7 Federal Agency For Medicines And Health Products / / Health Products Division 7 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 3 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 3 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 3 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 2 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 State Health Care Accreditation Agency Under The Ministry Of Health Of The Republic Of Lithuania 2 State Institute For Drug Control Medical Device Section 2 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 De/Ca39, Regierungspräsidium Freiburg Referat 25 1 Health Products Regulatory Authority, Medical Devices Department 1 State Agency Of Medicines, Department Of Medical Devices 1 The Norwegian Medical Products Agency 1 + More Competent Authorities

Kind

Kit 74 Reagent 73 Professional Testing 65 Animal Tissues 47 Self Testing 24 Near Patient Testing 15 Microbial Substances 14 Single Use 13 Human Tissues 10 Companion Diagnostics 3 Sterilization 2 + More Kinds

Classification

FDA Class 2 99 Eu Ivd General 69 FDA Class 1 56 FDA Class 3 39 Eu Ivd Self Testing 22 Eu Md Class 1 17 Eu Ivd Class A 7 Eu Ivd Class B 6 Eu Md Class 2a 3 + More Classifications

Notified Body

Tüv Süd Product Service Gmb H 16 Tüv Rheinland Lga Products Gmb H 6 + More Notified Bodies

FDA FEI Number

3015550354 64 1616487 58 3010057495 58 1000442352 56 1832216 56 1000135102 55 1181121 55 2939693 54 3006198300 54 3003071743 53 3004192065 53 3005146313 53 3013660430 53 3001236905 35 1000208624 28 1000512168 28 1043214 28 1000219637 26 3005747797 26 1000112877 25 + More FDA FEI Numbers

Regulation

Us FDA 1k Eu Ivdd 91 Eu Mdr 20 Eu Ivdr 13 + More Regulations

Authorized Representative

Shanghai International Holding Corp. Gmb H(europe) 38 Cmc Medical Devices & Drugs Sl 37 Lotus Nl B.V. 24 Humiss International B.V. 17 Med Path Gmb H 17 Med Net Ec Rep Gmb H 10 Osen Gmb H 10 Medunion S.L. 9 Sungo Cert Gmb H 8 Sungo Europe B.V. 7 Qb D Rep S Bv 5 Riomavix Ltd 4 Mdss Gmb H 3 Medical Technology Promedt Consulting Gmb H 3 Osmunda Medical Technology Service Gmb H 3 Med Envoy Global Bv 2 Nic Gmb H 2 Pride Mobility Products Europe Bv 2 Tosoh Europe N.V. 2 Trate Uab 2 + More Authorized Representatives

FDA Registration Number

3015550354 64 1063851 60 1616487 58 3010057495 58 1832216 56 1064608 55 1181121 55 2085064 54 2939693 54 3006198300 54 3004192065 53 3005146313 53 3013660430 53 1423537 36 1043214 28 1060680 28 1061124 28 1058584 26 3011137372 26 1054241 25 + More FDA Registration Numbers

FDA K Number

K010670 1 K020808 1 K770450 1 K770752 1 K771658 1 K781460 1 K781635 1 K790640 1 K792400 1 K792531 1 K792605 1 K800683 1 K802163 1 K803013 1 K812181 1 K820235 1 K832438 1 K833166 1 K833746 1 K834333 1 + More FDA K Numbers

Certificate Type

Ivdd Annex Iv (Excluding Sections 4, 6) 22 + More Certificate Types

Status

On The Market 17 + More Statuses

MedPath GmbH

Authorized representative

🇩🇪 Germany·537 Manufacturers·13464 Devices

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

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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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