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BEUDAMED

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681 results · 36ms · Sources: EU EUDAMED, US FDA

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FDA UDI 410 FDA registration 153 FDA 510(k) 100 Basic UDI-DI 7 Device 7 FDA classification 3 Importer 1 + More Filters

Country

United States 588 Germany 16 United Kingdom 15 China 13 Japan 7 Canada 6 South Korea 6 Pakistan 4 Hungary 3 Ireland 3 Spain 3 Brazil 2 Czechia 2 Denmark 2 Finland 2 France 2 Italy 2 Singapore 2 Switzerland 1 Taiwan 1 + More Countries

Manufacturer

Fare Tec Inc 4 Respironics Inc. 3 Gc Medical Science Corporation 2 Abd Srl 1 Kh Medical Co., Ltd. 1 Luxxamed Gmb H 1 Shenzhen Mindray Bio Medical Electronics Co., Ltd. 1 Takeda Pharmaceuticals U.S.A., Inc. 1 + More Manufacturers

Competent Authority

Agencia Española De Medicamentos Y Productos Sanitarios 4 De/Ca70 Landesamt Für Umwelt Und Arbeitsschutz 3 Ministry Of Health, Welfare And Sports 3 De/Ca05 Behorde Fur Justiz Und Verbraucherschutz 1 De/Ca21 Bezirksregierung Köln Dezernat 24 1 De/Ca30 Regierungspräsidium Kassel Dezernat 55 Medizinprodukte Und Produktsicherheitsrecht 1 Health Products Regulatory Authority, Medical Devices Department 1 Ministry Of Health Directorate General Of Medical Devices And Pharmaceutical Services 1 + More Competent Authorities

Kind

Professional Testing 5 Reagent 4 Kit 3 Animal Tissues 2 Human Tissues 2 Near Patient Testing 2 Active 1 Instrument 1 Software 1 + More Kinds

Classification

FDA Class 1 91 FDA Class 2 12 Eu Md Class 1 7 Eu Ivd General 3 Eu Md Class 2a 2 Eu Ivd Class A 1 Eu Ivd Class B 1 + More Classifications

Notified Body

Tüv Nord Cert Gmb H 1 + More Notified Bodies

FDA FEI Number

2432235 102 1827821 96 1000306617 93 1219913 93 2122870 93 2245285 93 3002800697 93 3002806559 93 3002806944 93 2967 92 3002808328 92 1000121039 91 1415939 91 2020726 91 2182595 91 2517506 91 3000717645 91 3002485711 91 3002806808 91 3002808140 91 + More FDA FEI Numbers

Regulation

Us FDA 666 Eu Mdr 5 Eu Mdd 4 Eu Ivdd 3 Eu Ivdr 2 + More Regulations

Authorized Representative

Cmc Medical Devices & Drugs Sl 4 Medical Technology Promedt Consulting Gmb H 3 Philips Medical Systems Nederland B.V. 3 Respironics Deutschland Gmb H & Co.Kg 3 Shanghai International Holding Corp. Gmb H(europe) 1 Shire Pharmaceuticals Ireland Limited 1 Takeda Manufacturing Austria Ag 1 Takeda Pharmaceuticals International Ag Ireland Branch 1 + More Authorized Representatives

FDA Registration Number

2432235 102 1827821 96 1219913 93 2029372 93 2122870 93 2245285 93 3002800697 93 3002806944 93 3005333358 92 3005529799 92 3007118747 92 9610126 92 1222302 91 1415939 91 2020726 91 2032087 91 2133982 91 2182595 91 2517506 91 3002809144 91 + More FDA Registration Numbers

FDA K Number

Den180040 1 K000043 1 K001086 1 K001935 1 K002294 1 K002674 1 K014120 1 K021326 1 K021972 1 K023091 1 K023860 1 K030730 1 K031717 1 K032881 1 K041866 1 K050576 1 K052649 1 K060818 1 K083867 1 K091867 1 + More FDA K Numbers

Certificate Type

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

Status

On The Market 7 + More Statuses

Immulite Analyzer

FDA registration

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC.·59 products·🇺🇸 United States

<1 …31 32 33 34 35 >

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

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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.

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