QLB - BEUDAMED

BEUDAMED

⌘K

API Documentation Get API Key Sign in By OpenRegulatory ↗

1,461 results · 33ms · Sources: EU EUDAMED, US FDA

Filter by

FDA UDI 788 FDA registration 494 FDA 510(k) 95 Basic UDI-DI 45 FDA Pre-Market Approval 20 Manufacturer 5 Device 4 FDA classification 4 Importer 4 Authorized representative 2 + More Filters

Country

United States 887 Netherlands 185 Australia 178 United Kingdom 101 South Korea 27 China 19 Sweden 13 Brazil 10 France 7 Germany 6 Canada 5 Lebanon 4 Austria 2 Belgium 2 Italy 2 Japan 2 Pakistan 2 Switzerland 2 Egypt 1 Finland 1 + More Countries

Manufacturer

Nordic Activity Ab 12 B&L Biotech 11 Hangzhou Tappa Medical Technology Co , Ltd. 6 Innomed, Inc. 4 Beckman Coulter Inc. 3 Maccura Biotechnology Co., Ltd. 3 G Flex Flexible Instruments Europe 2 Gencurix Inc. 2 Optolane Technologies Inc. 2 Shenzhen Am Tech Bioengineering Ltd., Inc. 2 Alamin For Modern Industries 1 Jilin Fulanns Medical Technology Co.,Ltd 1 Xiaotao Dingcheng Non Woven Products Co., Ltd 1 1drop Inc. 1 2 L Bio Co., Ltd. 1 A & J Dental Products International 1 A1 Globe Sdn. Bhd. 1 Aamedix Glove Sdn Bhd 1 Abi Enterprises 1 Accutron 1 + More Manufacturers

Competent Authority

Ministry Of Health, Welfare And Sports 19 Swedish Medical Products Agency 12 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 7 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 6 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 3 Health Products Regulatory Authority, Medical Devices Department 3 Agencia Española De Medicamentos Y Productos Sanitarios 2 Federal Agency For Medicines And Health Products / / Health Products Division 2 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 2 Austrian National Public Health Institute 1 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 1 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 1 + More Competent Authorities

Kind

Active 13 Professional Testing 13 Reagent 12 Reusable 11 Kit 7 Animal Tissues 4 Sterilization 4 Human Tissues 2 Instrument 1 Near Patient Testing 1 + More Kinds

Classification

FDA Class 2 76 Eu Md Class 1 36 FDA Class 1 22 FDA Class 3 20 Eu Ivd General 10 Eu Ivd Class A 2 Eu Ivd Class B 1 + More Classifications

Notified Body

Tüv Süd Product Service Gmb H 6 + More Notified Bodies

FDA FEI Number

3018783526 184 3011416394 99 3006410968 62 3018094310 42 1928237 33 3002806559 31 1045254 29 3006198300 29 3011050570 29 3002806560 28 3003795116 28 3012494290 27 1048735 26 3003790304 25 3013557562 25 1037007 24 1417592 23 2183744 21 1926681 20 2050010 20 + More FDA FEI Numbers

Regulation

Us FDA 1k Eu Mdr 20 Eu Mdd 16 Eu Ivdd 10 Eu Ivdr 3 + More Regulations

Authorized Representative

Emergo Europe B.V. 11 Prolinx Gmb H 6 Cmc Medical Devices & Drugs Sl 4 Medi Mark Europe Sarl. 4 Shanghai International Holding Corp. Gmb H(europe) 4 Beckman Coulter Ireland Inc. 3 Humiss International B.V. 3 Medical Technology Promedt Consulting Gmb H 2 Sungo Europe B.V. 2 Arkray Europe, B.V. 1 Lotus Nl B.V. 1 Riomavix Ltd 1 + More Authorized Representatives

FDA Registration Number

3018783526 184 3011416394 99 3006410968 62 3018094310 42 1928237 33 9610126 31 1045254 29 3006198300 29 3011050570 29 3003795116 28 9610529 28 3012494290 27 1048735 26 3003790304 25 3013557562 25 1037007 24 1417592 23 2183744 21 1926681 20 2050010 20 + More FDA Registration Numbers

FDA K Number

K003640 1 K100237 1 K111724 1 K121114 1 K170596 1 K770263 1 K782007 1 K821415 1 K830629 1 K831037 1 K860525 1 K874270 1 K882032 1 K891167 1 K925210 1 K954073 1 K955448 1 K955814 1 K961436 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 6 + More Certificate Types

Status

On The Market 4 + More Statuses

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

<1 …70 71 72 73 74 >

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

BEUDAMED

A better medical device search engine by OpenRegulatory.

API Documentation
API Dashboard
EUDAMED API on GitHub
Imprint

BEUDAMED

Rationale
MDR Notified Bodies
MDR Competent Authorities

OpenRegulatory

OpenRegulatory
Formwork eQMS Software
Digital Health Jobs
EUDAMED Budget Monitor
eidel.io

Tools

510(k) Predicate Finder
Product Code Directory
510(k) Review Times
21 CFR Regulations
NB Comparison

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.

© 2026 OpenReg GmbH. All rights reserved.