Edwards Lifesciences LLC - BEUDAMED

BEUDAMED

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3,221 results · 105ms · Sources: EU EUDAMED, US FDA

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FDA UDI 2k FDA Pre-Market Approval 1k FDA registration 437 FDA 510(k) 138 Authorized representative 1 Importer 1 Manufacturer 1 System producer 1 + More Filters

Country

United States 3k Dominican Republic 30 Costa Rica 9 Singapore 7 Ireland 6 Netherlands 5 Germany 1 + More Countries

Manufacturer

Edwards Lifesciences Llc 2 Harpoon Medical, Inc. 1 + More Manufacturers

Competent Authority

De/Ca304 Marktüberwachung Medizinprodukte Bayern 3 Ministry Of Health, Welfare And Sports 1 + More Competent Authorities

Classification

FDA Class 3 1k FDA Class 2 137 FDA Class 1 1 + More Classifications

FDA FEI Number

2015691 1k 3007063218 1k 3005334138 1k 2025587 1k 3007113487 1k 3010432890 995 3014918977 995 3015287573 833 2011171 755 1713910 746 2648045 698 3002534070 631 3001883144 592 1721676 583 3012179728 573 3010421104 565 3017298588 499 3002807314 497 3002807111 495 3002806434 469 + More FDA FEI Numbers

Regulation

Us FDA 3k + More Regulations

Authorized Representative

Edwards Lifesciences Gmb H 1 + More Authorized Representatives

FDA Registration Number

2015691 1k 3007063218 1k 2025587 1k 2135147 1k 3007113487 1k 3010432890 995 3014918977 995 3015287573 833 2011171 755 3008500478 746 2648045 698 9617601 631 3001883144 592 1721676 583 3012179728 573 3010421104 565 3017298588 499 3002807314 497 3005941719 495 9612164 469 + More FDA Registration Numbers

TruWave Disposable Pressure Transducer

FDA Class 2 ·Cardiovascular

<1 …158 159 160 161 162 >

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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