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BEUDAMED

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5,661 results · 40ms · Sources: EU EUDAMED, US FDA

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FDA UDI 3k FDA registration 1k FDA 510(k) 769 FDA Pre-Market Approval 103 Basic UDI-DI 17 Device 11 FDA classification 3 Manufacturer 3 Authorized representative 2 Certificate 1 Importer 1 + More Filters

Country

United States 5k United Kingdom 401 China 78 Canada 62 Taiwan 43 Germany 37 Ireland 24 Israel 24 Switzerland 21 France 18 Spain 18 India 15 Malaysia 13 Australia 9 Japan 9 Hong Kong 8 Romania 8 Singapore 8 Türkiye 8 Mexico 7 + More Countries

Manufacturer

Kaz Europe Sàrl 8 Measurement Specialties Inc. 6 Ningbo Ks Medical Tech Co.,Ltd 4 Changsha Sinocare Inc. 2 Hangzhou Singclean Medical Products Co., Ltd. 2 Medster Tıbbi Cihaz Ve Sağlık Hizmetleri Ltd. şti. 2 Jade Scientific Inc. Dba American Scientific Products, Chem Pure Chemicals 1 Minaris Medical Co., Ltd. 1 1922 Pty Ltd 1 20/20 Medical Systems, Inc. 1 3 Nt Medical 1 A & I Industries Ltd Shunde Foshan 1 A Mi Global Co., Ltd. 1 A Spine Asia Co., Ltd. 1 Aaruy Medical (Guangdong) Co., Ltd. 1 Aaruy Medical Electronics Co., Ltd. 1 Across Industrial Co.,Ltd 1 Agd Biomedicals Pvt. Ltd 1 Aigene Co., Ltd. 1 Allmed Medical Textile Co.,Ltd (Viet Nam) 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 10 Health Products Regulatory Authority, Medical Devices Department 6 Ministry Of Health, Welfare And Sports 6 Turkish Medicine And Medical Devices Agency 5 Agencia Española De Medicamentos Y Productos Sanitarios 2 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 + More Competent Authorities

Kind

Active 8 Measuring Function 7 Single Use 3 Sterile 2 Instrument 1 Sterilization 1 + More Kinds

Classification

FDA Class 2 599 FDA Class 1 157 FDA Class 3 100 FDA Unclassified 15 Eu Md Class 2a 14 Eu Md Class 1 13 Eu Ivd Class A 1 + More Classifications

Notified Body

Dekra Certification B.V. 6 Dqs Medizinprodukte Gmb H 6 + More Notified Bodies

FDA FEI Number

3000126629 300 3009617712 281 3001104093 262 3005783425 257 1000122786 253 3003513129 253 3007603826 252 3009156722 252 3002558692 248 3000957797 246 3003319165 245 3010157426 244 2112667 242 2221819 235 1000114111 234 1218950 231 3021559257 230 3016618143 229 3007513035 218 3002808128 217 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Mdr 17 Eu Mdd 10 Eu Ivdr 1 + More Regulations

Authorized Representative

Obelis S.A. 9 Meas Ireland 6 Sungo Europe B.V. 4 Global E Commerce Experts Europe Bv 1 Karma Mobility S.L. 1 Medi Mark Europe Sarl. 1 + More Authorized Representatives

FDA Registration Number

3000126629 300 3009617712 282 3005783425 257 9611500 255 1000122786 253 3007603826 253 3009156722 253 9710602 252 9617604 247 1066270 246 3010157426 245 8043316 244 2112667 242 2221819 235 1054713 234 1218950 231 3021559257 230 3016618143 229 1066427 219 3001104093 216 + More FDA Registration Numbers

FDA K Number

K000706 1 K000859 1 K000995 1 K001315 1 K001488 1 K001727 1 K001988 1 K003251 1 K003579 1 K003663 1 K010613 1 K011404 1 K012446 1 K022031 1 K030624 1 K030939 1 K031400 1 K032803 1 K033026 1 K033498 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 6 Mdd Annex V 6 + More Certificate Types

Status

On The Market 11 + 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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