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7,521 results · 41ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 2k Basic UDI-DI 514 FDA Pre-Market Approval 478 FDA 510(k) 434 Device 229 Importer 13 Manufacturer 13 FDA classification 11 Authorized representative 6 System producer 1 + More Filters

Country

United States 4k China 2k Canada 685 Germany 477 Egypt 69 Taiwan 68 Mexico 38 Türkiye 32 Finland 28 Australia 27 Italy 22 Switzerland 17 United Kingdom 17 France 13 Pakistan 13 Hungary 10 South Korea 10 Singapore 9 Japan 8 India 7 + More Countries

Manufacturer

Biocyc Biotechnologie Gmb H & Co. Kg 415 Ba So Biotech Co., Ltd.. 55 Guilin Hbm Health Protections, Inc. 27 Dbc Global Oy 24 Eoca Md Pty Ltd 20 Beckman Coulter Inc. 19 Hbh Biotechnology Limited 18 Becker Orthopedic Appliance Company 9 Seleo S.R.L. 9 Besmed Health Business Corp. 8 Fujian Bbc Inc 8 Bros Med Medical Co., Ltd 6 N Ve H Medikal Ithalat Ihracat Pazarlama Ve Ticaret Anonim Sirketi 6 Daddy D Pro 4 Lgc Clinical Diagnostics, Inc. 4 Atlas Medical Gmb H 3 Hb Fuller, Medical Adhesive Technologies 3 Interrad Medical, Inc. 3 Quali Med Innovative Medizinprodukte Gmb H 3 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 3 + More Manufacturers

Competent Authority

De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 418 Health Products Regulatory Authority, Medical Devices Department 77 Agencia Española De Medicamentos Y Productos Sanitarios 63 Ministry Of Health, Welfare And Sports 56 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 26 Turkish Medicine And Medical Devices Agency 25 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 18 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 15 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 12 De/Ca38 Regierungspräsidium Karlsruhe 9 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 7 De/Ca304 Marktüberwachung Medizinprodukte Bayern 7 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 5 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 4 State Institute For Drug Control Medical Device Section 4 The Medicines And Healthcare Products Regulatory Agency 4 De/Ca10 Staatliches Gewerbeaufsichtsamt Lüneburg Abteilung 3 Medizinprodukte 3 De/Ca22 Bezirksregierung Münster 2 De/Ca30 Regierungspräsidium Kassel Dezernat 55 Medizinprodukte Und Produktsicherheitsrecht 2 De/Ca39, Regierungspräsidium Freiburg Referat 25 2 + More Competent Authorities

Kind

Professional Testing 440 Reagent 437 Human Tissues 417 Animal Tissues 414 Single Use 84 Sterile 61 Sterilization 27 Latex 23 Kit 18 Implantable 7 Microbial Substances 5 New Device 5 Reusable 5 Active 4 Software 4 Companion Diagnostics 3 Near Patient Testing 3 Instrument 2 Orthopedic 2 Administering Medicine 1 + More Kinds

Classification

FDA Class 3 447 Eu Ivd General 438 FDA Class 2 395 Eu Md Class 1 110 Eu Ivd Class A 85 FDA Class 1 69 Eu Md Class 2a 65 Eu Md Class 2b 16 Eu Ivd Annex 2 List A 12 Eu Md Class 3 9 Eu Ivd Annex 2 List B 5 Eu Ivd Class B 3 FDA Not Classified 1 FDA Unclassified 1 + More Classifications

Notified Body

Gmed Sas 15 Bsi Group The Netherlands B.V. 11 Tüv Rheinland Lga Products Gmb H 8 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 8 Dekra Certification B.V. 7 Kiwa Belgelendirme Hizmetleri A.ş. 5 Dekra Certification Gmb H 3 Dnv Product Assurance As 3 Elektrotechnický Zkušební ústav, S.P. 2 Ht Cert (Health Technology Certification Ltd) 2 Tüv Süd Product Service Gmb H 2 Dqs Medizinprodukte Gmb H 1 Kiwa Cermet Italia S.P.A. 1 Mtic Inter Cert S.R.L. 1 + More Notified Bodies

FDA FEI Number

3002806559 454 1219913 453 2432235 453 3002809144 453 3005333358 453 3015550354 453 2967 452 3002806944 452 3002808328 452 3008344661 452 1000306617 414 1000136573 390 2250051 390 3002642396 390 3003323921 390 3007111389 390 3012963943 390 1000122204 389 3000308930 365 3002808212 365 + More FDA FEI Numbers

Regulation

Us FDA 7k Eu Ivdd 455 Eu Mdr 147 Eu Ivdr 88 Eu Mdd 53 + More Regulations

Authorized Representative

Cmc Medical Devices & Drugs Sl 59 Hbm Medical 25 Af Pharma Service Europe Sl 20 Pbc Biomed Ltd 20 Beckman Coulter Ireland Inc. 19 Kingsmead Service B.V. 18 Sungo Europe B.V. 12 Shanghai International Holding Corp. Gmb H(europe) 11 Mdi Europa Gmb H 10 Acorn Regulatory Consultancy Services Ltd 9 Antex Medi Solution 8 Casus Europe B.V. 7 Brosmed Medical B.V. 6 Emergo Europe B.V. 5 Mdss Gmb H 4 Medi Mark Europe Sarl. 4 Khang Bao International Kft 3 Bricon Gmb H 2 Clonallon Laboratories (Ireland) Ltd 2 Eunitor Gmb H 2 + More Authorized Representatives

FDA Registration Number

1219913 453 2432235 453 3002809144 453 3005333358 453 3015550354 453 9610126 453 3002806944 452 3008344661 452 8031673 452 9612316 452 2029372 414 2032364 391 1319681 390 2250051 390 3002642396 390 3007111389 390 3012963943 390 2247117 389 2032682 365 3000308930 365 + More FDA Registration Numbers

FDA K Number

Den050002 1 K002523 1 K003612 1 K011444 1 K012453 1 K012457 1 K022986 1 K053526 1 K060260 1 K062368 1 K080444 1 K083112 1 K100464 1 K130497 1 K132264 1 K133604 1 K152960 1 K163565 1 K170312 1 K173066 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 34 Ivdd Annex V 12 Ivdd Annex Vii (Excluding Section 5) 12 Ivdd Annex Iv (Excluding Sections 4, 6) 11 Mdd Annex Ii Section 4 8 Mdd Annex V 6 + More Certificate Types

Status

On The Market 229 + More Statuses

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 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 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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