JEZ - BEUDAMED

BEUDAMED

⌘K

API Documentation Get API Key Sign in By OpenRegulatory ↗

6,901 results · 38ms · Sources: EU EUDAMED, US FDA

Filter by

FDA UDI 5k Device 777 FDA registration 574 FDA 510(k) 170 Basic UDI-DI 35 FDA Pre-Market Approval 19 Importer 14 FDA classification 10 Authorized representative 4 Manufacturer 4 + More Filters

Country

United States 6k Pakistan 704 China 143 Germany 106 Taiwan 96 South Korea 52 Ireland 20 United Kingdom 20 Philippines 19 Canada 15 Hungary 13 India 10 Denmark 8 Poland 8 Czechia 7 Netherlands 7 Switzerland 7 France 6 Brazil 5 Costa Rica 5 + More Countries

Manufacturer

Daud Jee Mfg. Co 661 Jem Healthcare Co., Ltd. 96 Benostan Health Products ανωνυμη εταιρεια παραγωγησ και εμποριασ καλλυντικων, φαρμακευτικων και συναφων προιοντων / Benostan Health Products α.ε. 16 Patella 96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság 11 Bio Plus Co., Ltd. 6 Dr. Müller Pharma S.R.O. 6 Bio Gnost Ltd. 5 Jiangsu Bioperfectus Technologies Co., Ltd. 4 "Biomed Lublin" Wytwórnia Surowic I Szczepionek Spółka Akcyjna 3 Eye Technology Limited 3 Mani, Inc. 3 Medicel Ag 3 Safeguard Medical Technologies Ltd. 3 Sterimedix Ltd 3 Water Jel Technologies, Llc 3 "Phin Consulting" Spółka Z Ograniczoną Odpowiedzialnością 2 Airs Medical Inc. 2 Bio Tech Vision Care Pvt. Ltd. 2 Beijing Choice Electronic Technology Co., Ltd. 2 Blink Medical Ltd. 2 + More Manufacturers

Competent Authority

Agencia Española De Medicamentos Y Productos Sanitarios 658 Ministry Of Health, Welfare And Sports 97 National Organisation For Medicines 16 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 13 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 8 State Institute For Drug Control Medical Device Section 7 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 6 Agency For Medicinal Products And Medical Devices 5 Malta Medicines Authority 5 De/Ca22 Bezirksregierung Münster 4 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 3 Health Products Regulatory Authority, Medical Devices Department 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 1 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 1 Federal Agency For Medicines And Health Products / / Health Products Division 1 Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 National Agency For Medicines And Medical Devices Of Romania 1 The Medicines And Healthcare Products Regulatory Agency 1 + More Competent Authorities

Kind

Single Use 98 Latex 21 Sterilization 10 Reusable 8 Professional Testing 6 Sterile 6 Microbial Substances 5 Reagent 5 Animal Tissues 4 Kit 4 Implantable 3 Administering Medicine 1 Cmr Substance 1 Companion Diagnostics 1 Human Tissues 1 Instrument 1 Measuring Function 1 + More Kinds

Classification

Eu Md Class 1 783 FDA Class 2 149 FDA Class 1 33 FDA Class 3 15 Eu Md Class 2a 8 Eu Ivd Class A 6 Eu Md Class 3 6 Eu Ivd Class C 4 Eu Ivd General 4 Eu Md Class 2b 1 FDA Not Classified 1 FDA Unclassified 1 + More Classifications

Notified Body

National Evaluation Center Of Quality And Technology In Health S.A. Ekapty 16 Szutest Uygunluk Değerlendirme A.ş. 6 + More Notified Bodies

FDA FEI Number

1000306431 83 3001236277 82 1000219637 78 2011171 69 3010425778 66 1043214 65 3000215273 65 3010273872 65 3013557562 65 3003477135 64 1000121056 62 1000136478 62 1526711 62 1721676 62 1526534 61 2245304 61 2648623 61 3002806565 61 3012494290 61 1000112877 60 + More FDA FEI Numbers

Regulation

Us FDA 6k Eu Mdr 776 Eu Mdd 22 Eu Ivdr 10 Eu Ivdd 4 + More Regulations

Authorized Representative

Cmc Medical Devices & Drugs Sl 656 Sungo Europe B.V. 96 Ktr Europe Gmb H 6 Shanghai International Holding Corp. Gmb H(europe) 5 Med Net Ec Rep Gmb H 4 Advena Limited 3 Khang Bao International Kft 1 + More Authorized Representatives

FDA Registration Number

1649518 85 2029275 80 1058584 78 1423662 66 3010425778 66 1043214 65 3010273872 65 3013557562 65 3003477135 64 1000121056 62 1319660 62 1526711 62 1721676 62 1424263 61 1526534 61 2245304 61 2648623 61 3012494290 61 9681260 61 1054241 60 + More FDA Registration Numbers

FDA K Number

Den170024 1 K011612 1 K012464 1 K021813 1 K022613 1 K033590 1 K060782 1 K072404 1 K080779 1 K082858 1 K083811 1 K090848 1 K110958 1 K111313 1 K113312 1 K143115 1 K161165 1 K192349 1 K202071 1 K202222 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii Section 4 22 + More Certificate Types

Status

On The Market 776 Not Intended For Eu Market 1 + More Statuses

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

<1 …342 343 344 345 346 >

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.