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BEUDAMED

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1,541 results · 50ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k FDA Pre-Market Approval 92 FDA 510(k) 89 FDA registration 48 Device 40 Basic UDI-DI 11 FDA classification 2 + More Filters

Country

United States 1k France 25 Pakistan 12 Malaysia 7 China 6 Mexico 4 Türkiye 4 Hong Kong 3 Italy 3 Netherlands 2 Germany 1 Switzerland 1 Taiwan 1 United Kingdom 1 + More Countries

Manufacturer

Prodont Holliger 24 Ar Instrumed 6 Lipuma 6 Armor Dental Corp 2 Abd Srl 1 Atlas Cerrahi̇ Aletler Ltd. şti̇. 1 Advanced Technology Research (A.T.R.) S:R.L. 1 Asel Tibbi Aletler A.S. 1 Aseptico, Inc. 1 Foshan Coxo Medical Instrument Co., Ltd. 1 Mk Dent Gmb H 1 Micro Mega Sa 1 Nextmed S.R.L.S. 1 Prime Dental Manufacturing 1 Samsun Cerrahi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 1 Samsun Mi̇kro Cerrahi̇ Aletler İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 1 + More Manufacturers

Competent Authority

Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 25 De/Ca38 Regierungspräsidium Karlsruhe 6 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 6 Turkish Medicine And Medical Devices Agency 4 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 3 Health Products Regulatory Authority, Medical Devices Department 2 Ministry Of Health, Welfare And Sports 2 De/Ca01 Landesamt Für Soziale Dienste Schleswig Holstein Abteilung 3 Gesundheits Und Verbraucherschutz 1 Malta Medicines Authority 1 + More Competent Authorities

Kind

Sterilization 38 Reusable 10 Single Use 3 Reprocessed 2 Professional Testing 1 Reagent 1 + More Kinds

Classification

FDA Class 3 99 FDA Class 2 80 Eu Md Class 1 43 Eu Md Class 2a 7 FDA Class 1 3 Eu Ivd Class A 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 1 Sgs Belgium Nv 1 Tüv Rheinland Lga Products Gmb H 1 Tüv Süd Product Service Gmb H 1 + More Notified Bodies

FDA FEI Number

3000719543 78 1000604079 75 3012316249 75 1924066 74 3004050971 74 3012494290 74 2129616 73 2523148 73 3004972304 73 3005380088 73 3010272829 73 3013557562 73 1314417 72 3004213967 72 3017865349 72 3003120897 39 3018094310 39 2124215 31 3004369318 31 3005700659 31 + More FDA FEI Numbers

Regulation

Us FDA 1k Eu Mdr 46 Eu Mdd 4 Eu Ivdr 1 + More Regulations

Authorized Representative

Antex Medi Solution 6 Ar Instrumed Deutschland Gmb H 6 Icon (Lr) Limited 2 Advena Limited 1 Emergo Europe B.V. 1 Lotus Nl B.V. 1 Med Envoy Global Bv 1 + More Authorized Representatives

FDA Registration Number

1062191 78 1000604079 75 3012316249 75 1924066 74 3004050971 74 3012494290 74 2523148 73 3004972304 73 3005380088 73 3009128734 73 3010272829 73 3013557562 73 1314417 72 3017865349 72 8030673 72 3003120897 39 3018094310 39 2124215 31 2135338 31 3004209178 31 + More FDA Registration Numbers

FDA K Number

K000890 1 K001412 1 K001579 1 K002284 1 K003455 1 K010389 1 K010747 1 K020329 1 K020475 1 K022865 1 K023420 1 K023673 1 K024023 1 K031983 1 K032018 1 K033197 1 K033364 1 K041057 1 K041568 1 K042142 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 2 Mdd Annex V 2 + More Certificate Types

Status

On The Market 40 + More Statuses

MyNotifi Rx

MEDHAB, LLC·00850023296009·MyNotifiRX: Is a Bluetooth wearable device that...

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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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