JCB - BEUDAMED

BEUDAMED

⌘K

API Documentation Get API Key Sign in By OpenRegulatory ↗

2,101 results · 44ms · Sources: EU EUDAMED, US FDA

Filter by

FDA UDI 1k FDA registration 428 Device 173 FDA Pre-Market Approval 160 FDA 510(k) 62 Basic UDI-DI 49 Manufacturer 9 Certificate 7 FDA classification 6 Importer 5 Authorized representative 4 + More Filters

Country

United States 2k China 108 Finland 89 Canada 85 Germany 29 Türkiye 26 South Korea 17 France 15 Italy 15 Indonesia 11 Netherlands 10 India 9 Austria 8 Switzerland 6 Belgium 5 Czechia 5 Pakistan 5 Poland 5 Taiwan 5 Japan 4 + More Countries

Manufacturer

Bcb Medical Oy 82 Shenzhen Jcr Medical Technology Limited Company 11 Biolux Technology Gmb H 6 Medi J Co., Ltd 5 Argon Medical Production & Vertriebs Gesellschaft Mb H & Co. Kg 4 Ortimplant Ortopedi Ve Tıbbi Aletleri Sanayi Ticaret Limited şirketi 4 Tulpar Tıbbi ürünler İthalat İhracat Sanayi Ve Ticaret L.T.D ş.T.İ 4 Vision Rx Lab Private Limited 4 Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted şi̇rketi̇ 3 Hasa Optix 3 Shenzhen Yurucheng Dental Materials Co., Ltd. 3 Syntropiq S.R.O. 3 Airs Medical Inc. 2 Atlas Cerrahi̇ Aletler Ltd. şti̇. 2 Alltrista Plastics Llc 2 Asel Tibbi Aletler A.S. 2 Bcb Medical Ab 2 Becker Orthopedic Appliance Company 2 Bicon, Llc 2 Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. A.ş 2 + More Manufacturers

Competent Authority

Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 84 Ministry Of Health, Welfare And Sports 37 Turkish Medicine And Medical Devices Agency 25 Federal Agency For Medicines And Health Products / / Health Products Division 13 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 9 Malta Medicines Authority 9 Austrian National Public Health Institute 7 Health Products Regulatory Authority, Medical Devices Department 7 Agencia Española De Medicamentos Y Productos Sanitarios 6 De/Ca32 Landesamt Für Soziales, Jugend Und Versorgung 5 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 4 De/Ca38 Regierungspräsidium Karlsruhe 4 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 4 State Institute For Drug Control Medical Device Section 4 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 4 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 3 De/Ca40 Regierungspräsidium Tübingen Referat 25 Sachgebiet Medizinprodukte 3 Swedish Medical Products Agency 3 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 2 De/Ca23 Regierungspräsidium Darmstadt Dezernat Iv/Da 45.2 2 + More Competent Authorities

Kind

Single Use 58 Sterile 37 Sterilization 20 Implantable 13 Active 11 Professional Testing 6 Reagent 5 Animal Tissues 4 Kit 4 Administering Medicine 2 Companion Diagnostics 2 Reusable 2 Instrument 1 Latex 1 Microbial Substances 1 Near Patient Testing 1 Orthopedic 1 Reprocessed 1 + More Kinds

Classification

FDA Class 3 160 Eu Md Class 2a 110 Eu Md Class 1 45 Eu Md Class 2b 41 FDA Class 2 34 FDA Class 1 33 Eu Md Class 3 15 Eu Ivd General 6 Eu Ivd Annex 2 List A 2 Eu Ivd Class A 2 Eu Ivd Annex 2 List B 1 FDA Not Classified 1 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 18 Bsi Group The Netherlands B.V. 13 Kiwa Belgelendirme Hizmetleri A.ş. 9 Polskie Centrum Badan I Certyfikacji S.A. 7 Slovenian Institute Of Quality And Metrology Siq 6 Ht Cert (Health Technology Certification Ltd) 5 Mtic Inter Cert S.R.L. 5 Udem Uluslararasi Belgelendirme Denetim Egitim Merkezi San. Ve Tic. A.ş. 5 Tuv Nord Polska Sp. Z O.O 3 Dekra Certification B.V. 2 Dekra Certification Gmb H 2 Intertek Semko Ab 2 Mdc Medical Device Certification Gmbh 2 Sgs Belgium Nv 2 Szutest Uygunluk Değerlendirme A.ş. 2 Dqs Medizinprodukte Gmb H 1 Ente Certificazione Macchine Srl 1 Italcert Srl 1 Neoemki Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (Neoemki Llc) 1 National Standards Authority Of Ireland (Nsai) 1 + More Notified Bodies

FDA FEI Number

2124215 161 3005099803 124 3013960851 124 3013987875 124 2246703 69 3010375065 69 2183744 51 1000138054 42 1000121056 35 3002806434 29 1313046 27 3001452571 27 3006513822 27 3006946276 27 3002750084 25 3003418325 24 3007208013 24 1820334 21 2433012 21 3002806565 21 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Mdr 129 Eu Mdd 82 Eu Ivdd 9 Eu Ivdr 2 + More Regulations

Authorized Representative

Lotus Nl B.V. 16 Advena Limited 7 Obelis S.A. 7 Sungo Europe B.V. 5 Cmc Medical Devices & Drugs Sl 4 Emergo Europe B.V. 3 Shanghai International Holding Corp. Gmb H(europe) 3 Share Info Consultant Service Llc 3 Umedwings Netherlands B.V. 3 Acorn Regulatory Consultancy Services Ltd 2 Bicon Europe Ltd 2 Europecert Ug (Haftungsbeschränkt) 2 Gc Aesthetics (Management) Limited 2 Humiss International B.V. 2 Osteo Care Implant System Ireland Limited 2 Riomavix Ltd 2 Phoenix Medtech Gmb H 2 Mps Medical Product Service Gmb H 1 Annie Bauer Confort 1 Antex Medi Solution 1 + More Authorized Representatives

FDA Registration Number

2124215 161 3005099803 124 3013960851 124 3013987875 124 2246703 69 3010375065 69 2183744 51 1319639 42 1000121056 35 9612164 29 1313046 27 2953200 27 3006513822 27 3006946276 27 1836161 25 3003418325 24 3007208013 24 1820334 21 2433012 21 3010273872 21 + More FDA Registration Numbers

FDA K Number

Den120008 1 K120986 1 K772345 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 48 Mdd Annex Ii Section 4 20 Mdd Annex V 15 Ivdd Annex Iv (Excluding Sections 4, 6) 3 Ivdd Annex Iv Section 4 2 Mdr Qa 2 Mdr Technical Documentation 1 + More Certificate Types

Status

On The Market 172 No Longer On The Market 1 + More Statuses

Lotus NL B.V.

Authorized representative

🇳🇱 Netherlands·584 Manufacturers·21427 Devices

<1 …102 103 104 105 106 >

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.