CBQ - BEUDAMED

BEUDAMED

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2,401 results · 39ms · Sources: EU EUDAMED, US FDA

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FDA UDI 1k FDA registration 1k FDA 510(k) 92 Device 63 FDA Pre-Market Approval 28 Basic UDI-DI 24 FDA classification 10 Manufacturer 7 Authorized representative 6 Importer 4 Certificate 1 + More Filters

Country

United States 1k Hong Kong 663 China 168 Taiwan 56 Italy 39 Germany 37 United Kingdom 33 Finland 22 Canada 16 Mexico 15 Japan 14 South Korea 8 Spain 6 Denmark 5 Netherlands 4 Estonia 3 India 3 Ireland 3 El Salvador 2 France 2 + More Countries

Manufacturer

Cbs Medical Srl 30 Chinabridge (Shenzhen) Medical Technology Co., Ltd. 24 Bq Plus Medical Co., Ltd. 10 Cbh Inc. 5 Yamakin Co., Ltd. 4 Biocyc Biotechnologie Gmb H & Co. Kg 4 The Binding Site Group Ltd 3 C Luminary Biotechnology Co., Ltd. 2 Industrias Hidráulicas Pardo Sl 2 Medical System Biotechnology Co., Ltd. 2 Zybio Inc. 2 Ai Insight Inc. 1 Air Water Realize Inc. 1 Accu Pulse Medical Device (Suzhou) Ltd. 1 Affacare Medical (Beijing) Co., Ltd. 1 Alfa Medtech (Shanghai) Co., Ltd. 1 Anhui Jn Medical Device Co.,Ltd. 1 Anhui Med Purest Medical Technology Co., Ltd. 1 Anji Anshen Surgical Dressings Co., Ltd. 1 Anntom Medica Limited 1 + More Manufacturers

Competent Authority

Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 60 Agencia Española De Medicamentos Y Productos Sanitarios 10 Health Products Regulatory Authority, Medical Devices Department 9 Ministry Of Health, Welfare And Sports 6 De/Ca20, Bezirksregierung Düsseldorf Dezernat 24 5 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 4 De/Ca76 Landesamt Für Arbeitsschutz, Verbraucherschutz Und Gesundheit Abt. Gesundheit Dezernat G4 4 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 2 Federal Agency For Medicines And Health Products / / Health Products Division 2 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 De/Ca37, Regierungspräsidium Stuttgart 1 De/Ca38 Regierungspräsidium Karlsruhe 1 + More Competent Authorities

Kind

Single Use 39 Sterile 9 Reagent 8 Kit 7 Professional Testing 7 Human Tissues 4 Animal Tissues 3 Active 2 Measuring Function 1 Near Patient Testing 1 Reusable 1 + More Kinds

Classification

FDA Class 2 92 Eu Md Class 1 41 FDA Class 3 28 Eu Md Class 2a 15 Eu Md Class 2b 14 Eu Ivd General 13 FDA Class 1 7 Eu Ivd Class B 3 Eu Ivd Class A 1 FDA Not Classified 1 FDA Unclassified 1 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 7 + More Notified Bodies

FDA FEI Number

3013557562 696 3000126629 44 3002806783 44 3002807167 41 3008729547 41 3003971136 39 3009617712 39 3002737156 35 3007603826 35 3009077524 35 2221819 34 3005877899 33 3009156722 33 3012528160 33 3013500228 33 3013596024 33 2026994 32 1000191380 30 3003263092 30 3003513129 30 + More FDA FEI Numbers

Regulation

Us FDA 2k Eu Mdr 64 Eu Ivdd 13 Eu Mdd 6 Eu Ivdr 4 + More Regulations

Authorized Representative

Cbm Lifemotion S.R.L. 24 Prolinx Gmb H 7 Zoustech S.L. 7 Meridius Medical Europe Limited 5 Lotus Nl B.V. 4 Medical Technology Promedt Consulting Gmb H 4 Sungo Cert Gmb H 3 The Binding Site Ireland Limited 3 Medunion S.L. 2 Qb D Rep S Bv 2 Shanghai International Holding Corp. Gmb H(europe) 2 Cb Healthcare Consulting Gmb H 1 Cbc (Europe) Srl 1 C Epartner4 U 1 Emergo Europe B.V. 1 Med Path Gmb H 1 Medwheat Tech Service Gmb H 1 Sungo Europe B.V. 1 + More Authorized Representatives

FDA Registration Number

3013557562 696 3000126629 44 9610105 43 3008729547 41 3003971136 40 9610816 40 3009617712 39 1651104 35 3007603826 35 3009077524 35 2221819 34 3005877899 33 3009156722 33 3012528160 33 3013500228 33 3013596024 33 2026994 32 3003263092 31 3004415095 31 1000191380 30 + More FDA Registration Numbers

FDA K Number

Den220083 1 K012576 1 K021981 1 K022750 1 K031563 1 K032254 1 K034032 1 K040917 1 K123144 1 K160481 1 K193586 1 K233452 1 K760082 1 K770547 1 K770964 1 K772003 1 K772114 1 K780703 1 K780729 1 K781022 1 + More FDA K Numbers

Certificate Type

Mdd Annex V 7 + More Certificate Types

Status

On The Market 62 No Longer On The Market 1 + More Statuses

Alpha-1-Fetoprotein (AFP) - RP001, PDR013

FDA registration

DIAGNOSTIC BIOSYSTEMS·1 product·🇺🇸 United States

<1 …117 118 119 120 121 >

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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