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BEUDAMED

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101 results · 111ms · Sources: EU EUDAMED, US FDA

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FDA UDI 96 Authorized representative 2 FDA 510(k) 2 Manufacturer 1 + More Filters

Country

United States 96 Australia 3 Bulgaria 1 Netherlands 1 + More Countries

Manufacturer

Musculoskeletal Transplant Foundation 1 3 D Industrial Imaging Co.Ltd 1 7 D Surgical Ulc 1 A&D Company, Limited 1 A M Systems 1 Active Life Scientific, Inc. 1 Acutronic Medical Systems Ag 1 Ag Industries Llc 1 Ai Optics Private Limited 1 Ain Medicare Sdn Bhd 1 Air Water Realize Inc. 1 Amtec Co., Ltd. 1 Angelus Indústria De Produtos Odontológicos S/A 1 Ark Diagnostics, Inc. 1 Asahi Intecc Co., Ltd. 1 Astec Co.,Ltd 1 Asti Corporation 1 Ava Sciences Fmtc Llc 1 Avita Medical Americas, Llc 1 Azena Medical, Llc 1 + More Manufacturers

Competent Authority

Bulgarian Drug Agency Department "Market Supervision And Lnspections" Division "Medical Devices" 2 Ministry Of Health, Welfare And Sports 1 + More Competent Authorities

Classification

FDA Class 2 2 + More Classifications

FDA FEI Number

2916714 2 3002821504 2 + More FDA FEI Numbers

Regulation

Us FDA 98 + More Regulations

Authorized Representative

Compliance Management Solutions Europe Ltd 1 + More Authorized Representatives

FDA Registration Number

2916714 2 8010177 2 + More FDA Registration Numbers

SPECTRALIS, HRT3, HEP

Heidelberg Engineering GmbH·04059237000242·

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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