FHA - BEUDAMED

BEUDAMED

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5,461 results · 37ms · Sources: EU EUDAMED, US FDA

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FDA registration 3k FDA UDI 2k FDA 510(k) 270 Device 237 FDA Pre-Market Approval 125 Basic UDI-DI 60 FDA classification 60 Importer 10 Authorized representative 5 Manufacturer 4 System producer 1 + More Filters

Country

United States 2k China 869 Vietnam 291 Taiwan 289 Italy 213 South Korea 186 Hong Kong 173 Finland 168 Israel 132 Pakistan 100 India 94 Germany 66 United Arab Emirates 57 Japan 51 United Kingdom 30 Canada 26 France 26 Malaysia 25 Spain 23 Mexico 18 + More Countries

Manufacturer

Air Life Finland Oy 162 Fhq Trading Co. 86 Xiang Fa Li Technology (Xiamen) Co.,Ltd 7 Fysicon B.V. 6 Wilson Instruments (Sha) Co., Ltd. 5 Abon Biopharm(hangzhou) Co., Ltd 4 Anrei Medical (Hz) Co., Ltd. 4 Asahi Intecc Co., Ltd. 3 Daddy D Pro 3 Shangxian Minimal Invasive Inc. 3 Arkray Factory, Inc. 2 Ava Fa Kft. 2 Alton (Shanghai) Medical Instruments Co., Ltd. 2 Beijing Zksk Technology Co., Ltd 2 Changzhou Intl. Trade & Enterprises Cooperative Co.,Ltd. 2 Changzhou Jiuhong Medical Instrument Co., Ltd. 2 Eltek Instruments Pvt Ltd 2 Endo Aid Ltd. 2 Evidencio 2 Foresight Technology Co., Ltd. 2 + More Manufacturers

Competent Authority

Finnish Medicines Agency, Supervision And Licences, Medical Device Unit 164 De/Ca38 Regierungspräsidium Karlsruhe 88 Ministry Of Health, Welfare And Sports 25 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 4 Turkish Medicine And Medical Devices Agency 4 Austrian National Public Health Institute 3 National Agency For Medicines And Medical Devices Of Romania 3 Nemzeti Népegészségügyi és Gyógyszerészeti Központ 3 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 2 Federal Agency For Medicines And Health Products / / Health Products Division 2 Health Products Regulatory Authority, Medical Devices Department 2 štátny ústav Pre Kontrolu Liečiv / State Institute For Drug Control ( Slovak Ca) 2 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 1 De/Ca22 Bezirksregierung Münster 1 De/Ca29 Regierungspräsidium Darmstadt Abteilung Arbeitsschutz Und Umwelt 1 De/Ca304 Marktüberwachung Medizinprodukte Bayern 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 National Organisation For Medicines 1 Office Of Public Health 1 + More Competent Authorities

Kind

Single Use 50 Reusable 42 Sterilization 7 Professional Testing 5 Reagent 5 Active 4 Animal Tissues 4 Kit 4 Sterile 4 Software 3 Implantable 1 Microbial Substances 1 + More Kinds

Classification

Eu Md Class 1 277 FDA Class 2 275 FDA Class 3 134 FDA Class 1 38 Eu Md Class 2a 9 Eu Ivd General 6 FDA Not Classified 5 Eu Md Class 2b 3 Eu Md Class 3 2 FDA Unclassified 2 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 3 Dekra Certification B.V. 2 Szutest Uygunluk Değerlendirme A.ş. 2 Mtic Inter Cert S.R.L. 1 + More Notified Bodies

FDA FEI Number

3015550354 103 3016727307 93 3010303097 91 3004192065 85 3011522054 84 3004635103 83 3007606081 83 1036362 74 2124215 74 1000206808 73 2122870 73 2432235 73 3000215273 73 3001451797 73 3002637618 73 3002806559 73 3005333358 73 3006198300 73 3007135420 73 3016438761 73 + More FDA FEI Numbers

Regulation

Us FDA 5k Eu Mdr 279 Eu Mdd 12 Eu Ivdd 6 + More Regulations

Authorized Representative

Antex Medi Solution 87 Cs Active 84 Sungo Europe B.V. 7 Medical Technology Promedt Consulting Gmb H 4 Emergo Europe B.V. 3 Arkray Europe, B.V. 2 Cmi Spol. S R.O. 2 Ar Experts B.V. 1 Blue Broccoli Gmb H 1 Certification Experts 1 E C Rep Limited 1 Europecert Ug (Haftungsbeschränkt) 1 Holistic Business Excellence Gmb H 1 Med Path Gmb H 1 Obelis S.A. 1 Pride Mobility Products Europe Bv 1 Quality First International Oü 1 Samsung Electronics Gmb H 1 Termobit Prod Srl 1 + More Authorized Representatives

FDA Registration Number

3015550354 103 3016727307 93 3010303097 91 3004192065 85 3011522054 84 3004635103 83 3007606081 83 1036362 74 2124215 74 1423662 73 1649661 73 2122870 73 2432235 73 3002637618 73 3005333358 73 3006198300 73 3007135420 73 3016438761 73 9610126 73 9680746 73 + More FDA Registration Numbers

FDA K Number

Den190035 1 Den220014 1 K000844 1 K001767 1 K002148 1 K003178 1 K003696 1 K013678 1 K013857 1 K022680 1 K022681 1 K031052 1 K033234 1 K033391 1 K040187 1 K042676 1 K060548 1 K063720 1 K063754 1 K072438 1 + More FDA K Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 7 Mdd Annex Ii Section 4 2 Mdd Annex V 1 + More Certificate Types

Status

On The Market 236 No Longer On The Market 1 + More Statuses

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 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

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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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