NFY - BEUDAMED

BEUDAMED

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6,101 results · 42ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 2k FDA Pre-Market Approval 759 FDA 510(k) 428 Device 93 Basic UDI-DI 76 Manufacturer 21 Authorized representative 9 Importer 8 FDA classification 5 Certificate 4 + More Filters

Country

United States 4k Finland 804 Vietnam 392 China 192 Germany 163 Italy 104 Pakistan 101 Canada 71 France 67 Hong Kong 45 Nicaragua 40 Japan 39 South Korea 38 India 34 United Kingdom 28 Taiwan 23 Austria 17 Bulgaria 14 Australia 11 Estonia 8 + More Countries

Manufacturer

Afi Centrifuge 44 Northern Digital Inc. 36 Dfi Co.,Ltd. 26 Surgical Equipment Co. 19 Wenzhou Zhicheng Optical Mfy. Co.,Ltd 12 Intermark Medical Innovations Ltd 7 Group Akm Pty Ltd 6 Oy Diagnostic Devices Development 5 Pro Wellness Health Solutions Oy 4 Integri Medical Private Limited 3 Acon Laboratories, Inc. 2 Etiometry Inc. 2 Pneumeric Inc. 2 Samphire Neuroscience Ltd 2 E Life International Co., Ltd. 2 Pointimplant Co., Ltd. 1 Senbitec Co Ltd 1 1922 Pty Ltd 1 1drop Inc. 1 20/20 Medical Systems, Inc. 1 + More Manufacturers

Competent Authority

The Medicines And Healthcare Products Regulatory Agency 57 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 47 De/Ca39, Regierungspräsidium Freiburg Referat 25 38 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 25 Ministry Of Health, Welfare And Sports 17 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 15 Federal Agency For Medicines And Health Products / / Health Products Division 4 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 1 De/Ca38 Regierungspräsidium Karlsruhe 1 Malta Medicines Authority 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 1 State Agency Of Medicines, Department Of Medical Devices 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 Turkish Medicine And Medical Devices Agency 1 + More Competent Authorities

Kind

Single Use 29 Sterile 21 Active 16 Measuring Function 7 Software 7 Instrument 4 Professional Testing 4 Administering Medicine 3 Human Tissues 1 Sterilization 1 + More Kinds

Classification

FDA Class 3 759 FDA Class 2 363 Eu Md Class 1 85 FDA Class 1 68 Eu Ivd Class A 66 Eu Md Class 2a 14 Eu Md Class 2b 3 Eu Ivd General 1 FDA Unclassified 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 37 Eurofins Electric & Electronics Finland Oy 6 Sgs Belgium Nv 6 Sgs Fimko Oy 2 Tüv Rheinland Lga Products Gmb H 2 Tüv Süd Product Service Gmb H 1 + More Notified Bodies

FDA FEI Number

3018094310 843 1000306431 838 2011171 834 3016678045 833 2124215 754 3003120897 754 2649622 753 3009380063 753 3000206435 752 1828132 751 2648729 751 3002618605 751 3002807314 751 3006705815 751 1028232 750 2017865 750 2182208 750 2183787 750 2938836 750 3000215273 750 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Ivdr 66 Eu Mdd 51 Eu Mdr 51 Eu Ivdd 1 + More Regulations

Authorized Representative

Omc Ni Medical Limited 38 Ndi Europe Gmb H 36 Mdss Gmb H 24 Sungo Europe B.V. 14 Intermark Medical (Ni) Ltd 8 Group Akm Ni Ltd 7 Emergo Europe B.V. 3 Global Regulatory Solutions Hc B.V. 3 Obelis S.A. 3 C Epartner4 U 1 + More Authorized Representatives

FDA Registration Number

3018094310 843 2029275 838 2011171 834 3016678045 833 2124215 754 3003120897 754 2649622 753 3009380063 753 2030624 752 1828132 751 2648729 751 3002807314 751 3006705815 751 9616693 751 1028232 750 1423662 750 2017865 750 2032521 750 2182208 750 2183787 750 + More FDA Registration Numbers

FDA K Number

K832821 1 K840974 1 K843122 1 K843214 1 K854190 1 K900781 1 K932128 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 42 Mdd Annex Ii (Excluding Section 4) 9 Ivdr Qms 2 Mdd Annex Iii 1 + More Certificate Types

Status

On The Market 68 No Longer On The Market 15 Not Intended For Eu Market 10 + 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

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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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