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BEUDAMED

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6,121 results · 38ms · Sources: EU EUDAMED, US FDA

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FDA UDI 4k FDA Pre-Market Approval 1k FDA registration 432 FDA 510(k) 95 Device 31 Basic UDI-DI 16 FDA classification 9 Manufacturer 9 Authorized representative 5 Importer 5 Certificate 2 + More Filters

Country

United States 6k France 159 United Kingdom 59 Germany 42 India 18 Spain 15 Pakistan 13 Bulgaria 11 China 10 Malaysia 10 South Korea 7 Taiwan 7 Italy 5 Switzerland 5 Türkiye 4 Costa Rica 2 Dominican Republic 2 Hong Kong 2 Indonesia 2 Mexico 2 + More Countries

Manufacturer

Pps Manufacturing 11 Voe , S.A 11 Foxxmed Ltd 6 Shen Zhen Prs Limited. 4 Teco Medical Instruments, Production + Trading Gmb H 3 G P S S.R.L. 2 General Topics Srl 2 Internacional Ventur S.A. 2 Lifeward Ca, Inc. 2 Pms Tıbbi Cihazlar Teknolojisi Sanayi Ve Ticaret A.ş. 2 Px Dental Sa 2 Cixi Bld Medical Instrument Co., Ltd. 1 3 Cpm Company, Inc. 1 3 R Indústria E Comércio Ltda 1 A.B. Dental Devices Ltd 1 A.R Guide In Medical Ltd. 1 Acer Dentallab Co., Limited 1 Acme Tooling Technology Co., Ltd. 1 Ads Dental Lab Ltd. 1 Aie Tech Co., Ltd. 1 + More Manufacturers

Competent Authority

Agencia Española De Medicamentos Y Productos Sanitarios 14 Bulgarian Drug Agency Department "Market Supervision And Lnspections" Division "Medical Devices" 11 Federal Agency For Medicines And Health Products / / Health Products Division 8 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 6 Ministry Of Health, Welfare And Sports 6 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 5 De/Ca30 Regierungspräsidium Kassel Dezernat 55 Medizinprodukte Und Produktsicherheitsrecht 4 De/Ca304 Marktüberwachung Medizinprodukte Bayern 4 Turkish Medicine And Medical Devices Agency 4 Infarmed – National Authority Of Medicines And Health Products, I.P 2 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 1 De/Ca21 Bezirksregierung Köln Dezernat 24 1 De/Ca38 Regierungspräsidium Karlsruhe 1 De/Ca39, Regierungspräsidium Freiburg Referat 25 1 + More Competent Authorities

Kind

Single Use 19 Professional Testing 6 Animal Tissues 3 Reagent 3 Latex 2 Instrument 1 Kit 1 Near Patient Testing 1 Self Testing 1 + More Kinds

Classification

FDA Class 3 991 FDA Class 2 91 FDA Class 1 51 Eu Md Class 1 31 Eu Md Class 2a 8 Eu Ivd Class A 4 Eu Ivd General 3 FDA Unclassified 2 Eu Ivd Self Testing 1 + More Classifications

Notified Body

Szutest Uygunluk Değerlendirme A.ş. 6 Istituto Superiore Di Sanita' 4 Tüv Rheinland Lga Products Gmb H 1 + More Notified Bodies

FDA FEI Number

2124215 347 3009380063 326 3018094310 262 1028232 261 3005334138 261 3003120897 241 2182208 236 2011171 224 3000203466 224 2017865 223 3006705815 223 3002807314 218 3013288201 218 3008377825 213 3012552532 208 3002806500 203 1721676 202 3002807576 202 2183744 199 3003574398 199 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Mdr 31 Eu Mdd 8 Eu Ivdd 4 Eu Ivdr 4 + More Regulations

Authorized Representative

Obelis S.A. 8 Kingsmead Service B.V. 4 Px France Sàrl 2 Cinterqual Soluções De Comércio Internacional,Lda. 1 Mdss Gmb H 1 Phs Medical Gmb H 1 + More Authorized Representatives

FDA Registration Number

2124215 347 3009380063 326 3018094310 262 1028232 261 3003120897 241 2182208 236 2011171 224 2133641 224 2017865 223 3006705815 223 3002807314 218 3013288201 218 3008494315 213 3005334138 211 3012552532 208 9610139 203 1721676 202 9614453 202 2032521 199 2183744 199 + More FDA Registration Numbers

FDA K Number

K090755 1 K113235 1 K140581 1 K142128 1 K143344 1 K150010 1 K150034 1 K151237 1 K151628 1 K152857 1 K160419 1 K160855 1 K161039 1 K161045 1 K161141 1 K161811 1 K161963 1 K161979 1 K162188 1 K162254 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 8 Mdd Annex V 2 Ivdd Annex Iv (Excluding Sections 4, 6) 1 + More Certificate Types

Status

On The Market 31 + More Statuses

Kingsmead Service B.V.

Authorized representative

🇳🇱 Netherlands·243 Manufacturers·2698 Devices

<1 …303 304 305 306 307 >

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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